MAUDE Adverse Event Report: ZIMMER GMBH AVENIRA, RASP WITH TRUNNION CONNECTION, 4; AVENIR, RASP WITH TRUNNION CONNECTION, 4

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received per for review.The manufacturer did 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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

During surgery the instrument got stuck and kept slipping of the clutch.A link set had to be fetched, so that the rasp could be removed.An external system was used to complete the procedure.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g4, g7, h10 event summary: it was reported that during an initial hip surgery on (b)(6), 2020 the rasp size 4 got stuck and kept slipping of the clutch.An alternative instrument kit had to be used to remove the rasp, which resulted in a surgical delay of 30 minutes.Review of received data no patient data has been received due to patient privacy policy.Devices analysis - visual examination: the complained rasp was returned for examination.The trunnion shows discoloration and some wear on the edge.Further, especially in the proximal area some anchoring teeth are deformed, which occurred most likely during removal of the rasp, see images attached.Review of product documentation this device is intended for treatment.The compatibility check could not be performed as only the rasp has been reported.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary it was reported that during an initial hip surgery on (b)(6), 2020 the rasp size 4 got stuck and kept slipping of the clutch.An alternative instrument kit had to be used to remove the rasp, which resulted in a surgical delay of 30 minutes.No medical records such as surgical report have been provided due to patient privacy policy.The visual examination shows damages of the anchoring teeth in the proximal rasp and wear on the edge of the trunnion.The damages can be attributed to the removal attempts of the rasp from the femoral canal.Nothing that could lead or contribute to mechanical jam was identified.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).Therefore, we were not able to identify an exact root cause for the jamming of the rasp and the subsequent removal issues.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: AVENIRA, RASP WITH TRUNNION CONNECTION, 4
• Type of Device: AVENIR, RASP WITH TRUNNION CONNECTION, 4
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9685634
• MDR Text Key: 196744191
• Report Number: 0009613350-2020-00056
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00889024288607
• UDI-Public: 00889024288607
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• 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: 01.06620.004
• Device Lot Number: 4502942126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other