MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH POSITIONING GUIDE, 40, AV 12

Model Number N/A

Device Problem Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

During surgery it was noticed that the instruments have no grip on the handle.There was a delay of 40 minutes in surgery since the cemented pe cup had to be explanted again as it was in the wrong position.The instrument was used 100 times.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that during surgery it was noticed that the instruments have no grip on the handle.There was a delay of 40 minutes in surgery since the cemented pe cup had to be explanted again as it was in the wrong position.The instrument was used 100 times.Product evaluation: visual examination: the visual examination shows no considerable deteriorations, deformations or imperfections.The part shows some normal signs of usage.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: with the given information it cannot be determined whether the positioning guide was applied to the correct instrument handle.Neither the identification of the cup nor the identification of the handle is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that during surgery it was noticed that the instruments have no grip on the handle.There was a delay of 40 minutes in surgery since the cemented pe cup had to be explanted again as it was in the wrong position.The instrument was used 100 times.Based on the investigation the reported event could not be reproduced.The investigation did not identify a nonconformance or a complaint out of box (coob).In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the reported event.It is also not known whether the positioning guide was applied to the correct instrument handle.Neither the identification of the cup nor the identification of the handle is known.It is also possible that the instruments have reached the end of their lifetime as they have been on the market 8 resp.10 years.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 Description

Investigation results are available now.

• Brand Name: POSITIONING GUIDE, 40, AV 12
• Type of Device: POSITIONING GUIDE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10211652
• MDR Text Key: 197917622
• Report Number: 0009613350-2020-00295
• Device Sequence Number: 1
• Product Code: HWT
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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: 75.85.19
• Device Lot Number: 10.505174
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other