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

Model Number	N/A
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.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.(b)(4).
Event or Problem Description
During surgery the avenir extractor threads were damaged.The event happened while attempting to thread the extractor in stem.Vice grip slap hammer had been used to complete the procedure.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
Event description: during a hip revision the avenir stem extractor was used.In an attempt the thread the extractor into the stem the threads on the extractor were damaged and was rendered unable to use.Review of received data: 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: all parts of the extractor with sliding hammer were returned for investigation.The thread at the front of the device shows damages consisting of partly flattened thread turns.Based on this visual examination the reported event can be confirmed.Further, no conspicuousness could be identified.Functional test: a functional test was performed in order to assemble the two rod parts.It shows that these components can be assembled together without any issues.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: during a hip revision the avenir stem extractor was used.In an attempt the thread the extractor into the stem the threads on the extractor were damaged and was rendered unable to use.The complaint can be confirmed, based on the visual examination which revealed a damaged thread.Several conditions might have contributed to this failure, e.G.: contaminated thread by foreign particles or substances that change the force distribution; exceptionally high loads or loads in non-axial direction that may change the load distribution on the thread; or the thread is not fully tightened so that not all thread turns are loaded.However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The investigation did not identify a nonconformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer 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: EXTRACTOR WITH SLIDING HAMMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10850522
• Report Number: 0009613350-2020-00537
• Device Sequence Number: 3228051
• Product Code: HWB
• UDI-Device Identifier: 00889024288669
• UDI-Public: 00889024288669
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/03/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization