MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR NANO SLAP HAMMER; SHOULDER PROSTHESIS

Catalog Number 31-406921

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that during the revision procedure of a nano prosthesis, the surgeon couldn't use the slap hammer since the threads were damaged and the tip of the slap hammer was slightly bent.The surgery was delayed by 60 minutes to figure out an alternative way to get the prosthesis out.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

Visual examination of the returned product identified the slap hammer has damaged threads.There is some wear on the hammer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: COMPR NANO SLAP HAMMER
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8731798
• MDR Text Key: 149114592
• Report Number: 0001825034-2019-02551
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• PMA/PMN Number: K182516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 31-406921
• Device Lot Number: 590610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 08/20/2019; 06/15/2020
• Supplement Dates FDA Received: 08/26/2019; 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other