MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 190; WAGNER SL REVISION STEM LATERAL AND WAGNER CONE PROSTHESIS SYSTEM

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	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received photographs which will be reviewed as part of ongoing investigation.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.The lot number of the device was received.The device history records will be reviewed during investigation.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
It was reported that a screw head stripped.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: it was reported that the screw head is worn.A patient was not involved.Review of received data: no patient involvement, therefore no medical 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: the screw (ref.01.00109.809) was received for examination.The screw has scratches on the outer surface and a few worn threads.The head of the screw has a worn hexagonal female thread.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: the screw was manufactured in february 2007.The manufacturing documents were reviewed.Due to ensured functionality, there was a special clearance for machining marks found in the hexagonal female thread.Conclusion: it was reported that the screw head is worn.A patient was not involved.The scratches noted on the screw indicate that the screw is worn, possibly from repeated use, cleaning, and sterilization over a long period of time.The hexagonal female thread was found worn, possibly deriving from over-torquing.Since the device was manufactured in 2007, and based on the multiple signs of wear from usage, neither a nonconformance nor a complaint out of box (coob) was identified.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 or Problem Description
No event update.Investigation results are now available.

• Brand Name: WAGNER SL REVISION, SCREW FOR TRIAL STEM, L 190
• Common Device Name: WAGNER SL REVISION STEM LATERAL AND WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12915043
• Report Number: 0009613350-2021-00634
• Device Sequence Number: 14864204
• Product Code: LZO
• UDI-Device Identifier: 00889024278004
• UDI-Public: 00889024278004
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191781
• 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): 01/04/2022

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: 01.00109.809
• Device Lot Number: 07279756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Unknown