MAUDE Adverse Event Report: ZIMMER, INC. NATURAL KNEE SLAPHAMMER EXTRACTOR; KNEE INSTRUMENT

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.This report will be amended when our investigation is complete.

Event Description

It is reported that when the surgeon went to remove the femoral trial using the slaphammer extractor, the end of the instrument came off, leaving the shaft, slap handle, and end piece in three separate pieces.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device and review of photographs revealed a fracture at the weld and deformation and damage of the plate and pin.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends have been identified.Investigation results concluded that the reported event was due to repetitive use and the resulting wear and tear.This type of event is addressed in the associated risk documentation and package insert: "do not subject instruments to high loads and/or impact as breakage can occur" and "end of life is normally determined by wear and damage due to use".If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NATURAL KNEE SLAPHAMMER EXTRACTOR
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5801973
• MDR Text Key: 49759477
• Report Number: 0001822565-2016-02376
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 629000015
• Device Lot Number: 61787770
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR