MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION, IMPACTOR FOR STEM (LATERAL)

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received picture and per for review.The manufacturer received the device for investigation.Awhere 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 revision surgery, the wagner sl revision, impactor for stem was damaged on the threads.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that during a revision surgery, the wagner sl revision, the impactor for the stem was damaged on the threads.Review of received data: no other case-relevant documents received.Devices analysis: the two parts of the wagner sl impactor have been returned.Based on the returned product and the given information the complaint could be confirmed.The visual examination confirmed the thread of the inner rod (gewindestange mit schlagkopf) is damaged and therefore the two parts of instrument cannot be assembled anymore.Functional test: a functional test was performed.It shows that the rod (gewindestange mit schlagkopf) cannot be threaded in the handle (griff mit einschlagrohr) since the thread is damaged.Based on this functional test the reported event can be confirmed.Review of product documentation: this device is intended for treatment.Conclusion summary: it was reported that during a revision surgery, the impactor for the stem was damaged on the threads.The two parts of the wagner sl impactor have been returned.The visual examination confirmed the thread of the inner rod (gewindestange mit schlagkopf) is damaged.The functional test showed that the rod (gewindestange mit schlagkopf) cannot be threaded in the handle (griff mit einschlagrohr) because of the damaged thread.The reported event and the damaged thread indicate that the part have experienced excessively high forces.Abnormal use and wrong handling of the instrument could result in such a deformation.The investigation results did not identify a non-conformance 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).
Event or Problem Description
Investigation results are now available.

• Brand Name: WAGNER SL REVISION, IMPACTOR FOR STEM (LATERAL)
• Common Device Name: WAGNER SL REVISION, IMPACTOR FOR STEM (LATERAL)
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9436630
• Report Number: 0009613350-2019-00794
• Device Sequence Number: 3987121
• Product Code: HWA
• UDI-Device Identifier: 00889024277991
• UDI-Public: 00889024277991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 07/22/2020

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: 01.00109.808
• Device Lot Number: 07.337183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 07/22/2020
• 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
• Patient Age: 61 YR