FDA Adverse Event Injury Summary report: N

OFFSET 30 DEGREES BROACH HANDLE - LEFT

MDR report key: 3952775 · Received July 10, 2014

Report

Report Number: 3005180920-2014-00084
Event Type: Injury
Date Received: July 10, 2014
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: GET
Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

DOCUMENT REVIEW: OFFSET 30 DEGREES BROACH HANDLE LEFT: REF. 01.10.10.131 / LOT 1210184 (15 HANDLES PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. ALL THE HANDLES OF THE LOT ARE ON THE MARKET AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. WE DID NOT RECEIVE THE PRECISE LOT NUMBER OF THE AMISTEM BROACH SIZE 2 COUPLED WITH THE HANDLE, BUT WE GOT THREE POSSIBLE LOTS THAT WERE AVAILABLE IN THE HOSPITAL DURING THE SURGERY: AMISTEM BROACH SIZE 2, CODE 01.18.10.102: LOT 1111320,(B)(4) ITEMS PRODUCED ON JANUARY 20, 2012; NO ANOMALIES FOUND IN THE BATCH REVIEW. LOT 1112203, (B)(4) ITEMS PRODUCED ON JUNE 08, 2012; NO ANOMALIES FOUND IN THE BATCH REVIEW. LOT 1310508, (B)(4) ITEMS PRODUCED ON JULY 26, 2013; NO ANOMALIES FOUND IN THE BATCH REVIEW. ALL THE BROACHES OF THE THREE LOTS ARE ON THE MARKET AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

Description of Event or Problem · 1

REF IMP# (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
404586	OFFSET 30 DEGREES BROACH HANDLE - LEFT	SURGICAL INSTRUMENTS FOR HIP REPLACEMENT	GET	MEDACTA INTERNATIONAL SA

Patients

Seq	Age	Sex	Outcome	Treatment
1