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

Model Number N/A

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical products: extractor with sliding hammer; catalog#: 01.06808.300; lot#: 4502494397.The manufacturer received other source documents for review.The manufacturer did not receive 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 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.

Manufacturer Narrative

Investigation results were made available.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).

Event Description

No event update.Investigation results are now available.

• Brand Name: EXTRACTOR WITH SLIDING HAMMER
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12370325
• MDR Text Key: 269771619
• Report Number: 0009613350-2021-00433
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 00889024288669
• UDI-Public: 00889024288669
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.06808.300
• Device Lot Number: 4023552
• 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 Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization