MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH EXTRACTOR WITH SLIDING HAMMER; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical products: extractor with sliding hammer; catalog#: 01.06808.300; lot#: 4023552.The manufacturer received other source documents for review.The manufacturer received the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
During a surgery, while extracting an avenir stem the threads on the extractor got stripped.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Review of event description: it was reported that during surgery, the threads on the extractor got stripped when tried to extract an avenir stem.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Product evaluation: - visual examination: two extractor devices with sliding hammer were returned for investigation.The front threads of both devices show damage in the form of flattened threads.Review of product documentation: - device purpose: all involved devices are intended for treatment.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during surgery, the threads on the extractor got stripped when tried to extract an avenir stem.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The visual examination confirmed the damaged threads.Possible causes that could have caused or contributed to the damage include the application of unusually high loads or loads in a non-axial direction, as well as bone or tissue residues in the thread, or the thread is not fully tightened so that not all threads are loaded.However, based on the investigation, no exact cause could be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: EXTRACTOR WITH SLIDING HAMMER
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12370327
• Report Number: 0009613350-2021-00434
• Device Sequence Number: 3245142
• Product Code: HWA
• UDI-Device Identifier: 00889024288669
• UDI-Public: 00889024288669
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.06808.300
• Device Lot Number: 4502494397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization