FDA Adverse Event Malfunction Summary report: N

AIR PEN DRIVE

MDR report key: 8705310 · Received June 17, 2019

Report

Report Number: 8030965-2019-65068
Event Type: Malfunction
Date Received: June 17, 2019
Date of Event: January 1, 2019
Report Date: May 28, 2019
Manufacturer: DEPUY SYNTHES PRODUCTS LLC
Product Code: HBB
UDI-DI: 07611819830899
PMA / PMN Number: K093361
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UDI: (B)(4). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER MAINTENANCE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem · 1

IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR PEN DRIVE DEVICE WAS OUT OF SPECIFICATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK WITH TEST BENCH AND RECORD RESULTS; POWER: 30 TO 80 WATT(W) AND SPEED: MINIMUM 632 TO 1032 ROTATIONS PER MINUTE (RPM) AT 6.5 BAR ± 0.2 BAR. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
497804	AIR PEN DRIVE	MOTOR, DRILL, PNEUMATIC	HBB	DEPUY SYNTHES PRODUCTS LLC			07611819830899

Patients

Seq	Age	Sex	Outcome	Treatment
1