MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRIVER IMPACTOR-FEMORAL; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that an impactor fractured while impacting the implant.It fractured after the implant was already impacted and it did not delay the case.Attempts to obtain additional information have been made; however, no more information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.Corrected: h4 visual examination of the returned product identified signs of use and it is fractured.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.The root cause of the reported issue is attributed to wear and tear from repeated use of the instrument for twenty years.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: DRIVER IMPACTOR-FEMORAL
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12085281
• MDR Text Key: 259017702
• Report Number: 0001822565-2021-01772
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 00889024186262
• UDI-Public: (01)00889024186262(10)68770800
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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: 00133602800
• Device Lot Number: 68770800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 50 YR