MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SLAP HAMMER

Catalog Number 8732-7101

Device Problem Disassembly (1168)

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

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that an attachment pin fell out of a slap hammer during surgery.The pin fell into and was removed from the wound.An alternative instrument was not needed to complete the procedure.There were no reports of patient impacts associated with this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

Additional information: the returned slap hammer was evaluated.One of the quick connect attachment pins was found to have disassembled from the remainder of the device.The cause cannot be conclusively determined; however possible contributors include high forces placed on the device while trying to remove a too large trial, rasp, or spacer from the disc space or repetitive cleanings/washings.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: SLAP HAMMER
• Type of Device: HAMMER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6949984
• MDR Text Key: 90181145
• Report Number: 3012447612-2017-00558
• Device Sequence Number: 1
• Product Code: FZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8732-7101
• Device Lot Number: TU01095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1