FDA Adverse Event Malfunction Summary report: N

DORO DISPOSABLE SKULL PINS

MDR report key: 7057627 · Received November 24, 2017

Report

Report Number: 3003923584-2017-00050
Event Type: Malfunction
Date Received: November 24, 2017
Report Date: November 2, 2017
Manufacturer: PRO MED INSTRUMENTS GMBH
Product Code: HBL
PMA / PMN Number: K001808
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION RECEIVED BY THE CUSTOMER INDICATE, THAT THERE MIGHT HAVE BEEN AN INCIDENT DUE TO A POSSIBLE BREAKAGE OF THE PIN. AS WE DID NOT RECEIVE THE PRODUCT FOR INSPECTION WE COULD NOT CONFIRM OR EXCLUDE ANY BREAKAGE. HOWEVER CONSIDERING THE DETAILS OF THE CUSTOMER REPORT AND CONSIDERING THE TYPICAL USE OF THE PRODUCT DURING PINNING AND ESPECIALLY DURING RE-PINNING IT IS VERY UNLIKELY THAT A BREAKAGE WOULD NOT HAVE BEEN DETECTED BY THE USER. WE SUSPECT OTHER ROOT CAUSES FOR THE REPORTED INCIDENT.

Description of Event or Problem · 1

CUSTOMER MENTIONED ON THEIR REPLY FORM OF OUR FIELD SAFETY NOTICE 3006-00, LOT 17072 AND 17041 THE FOLLOWING: SINCE RECALL WAS REPORTED TO SURGEON, HE REPORTED, HIS LAST THREE PATIENTS HAD ISSUES WITH THE PRODUCTS. THIS REPLY FORM WAS RECEIVED ON NOVEMBER 2ND 2017. PMI CONTACTED THE CUSTOMER VIA PHONE ON (B)(6) WITHOUT SUCCESS AND WROTE AN EMAIL ON (B)(6) TO REQUEST FURTHER INFORMATION ABOUT THE DESCRIBED INCIDENTS. IN AN E-MAIL REPLY CUSTOMER STATED THAT THERE WERE NO INJURIES BUT THAT THE SURGEON HAS INDICATED THAT THERE WAS SOME INITIAL SLIPPAGE OF THE PINS WHEREBY THE CRANIUM DID MAINTAIN POSITION, WHICH WAS NEVER A PROBLEM BEFORE THE AFFECTT LOT WAS IN USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
837108	DORO DISPOSABLE SKULL PINS	DISPOSABLE SKULL PINS,ADULT (36PCS)	HBL	PRO MED INSTRUMENTS GMBH	3006-00	17041

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention