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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.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.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

It was reported that during surgery the thread of the instrument chipped off.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event summary: it was reported that during surgery, the threads are chipped.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.No other case-relevant documents received.Devices analysis: the product has not been returned for an investigation.However, pictures have been received.There is a dent in the threads of the threaded tip.No further conspicuousness detected.Review of product documentation: this device is intended for treatment.Conclusion summary: it was reported that during surgery, the threads are chipped.Based on the investigation the reported event can be confirmed.The investigation results did not identify a non-conformance or a complaint out of box (coob).The observed damage indicates that the part might have experienced an excessively high force, resulting in the dent at the threads.However, an exact root cause for the instrument damage could not be determined.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: WAGNER SL REVISION, IMPACTOR FOR STEM (LATERAL)
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9150959
• MDR Text Key: 196118172
• Report Number: 0009613350-2019-00590
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024277991
• UDI-Public: 00889024277991
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 01.00109.808
• Device Lot Number: 4502370093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1