MAUDE Adverse Event Report: ZIMMER GMBH MIS, RASP HANDLE, DOUBLE OFFSET, RIGHT; MIS DOUBLE OFFSET RASP HANDLE, RIGHT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received the documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the device, 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 the surgery, the spring mechanism of the mis rasp handle broke while impacting the rasp in patient.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: component broken.Event description: it was reported that the spring mechanism broke while impacting rasp in patient.Nothing fell into patient that had to be taken out.The patient did not retain any foreign bodies.There was no surgical delay.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: visual examination: visual inspection of the mis rasp handle shows that the locking lever has come off the rasp handle and the instrument is in two pieces.There is a small dent in the region, where the leaf spring of the locking lever touches the handle / housing in the locked position.Moreover, there are signs of excessive usage visible.Based on this visual examination the reported event can be confirmed.Review of product documentation: this device is intended for treatment.Conclusion: the disassembled rasp handle was returned for an investigation.The locking lever has come off the rasp handle.Due to excessive use there is a chamfer like contour in the housing, where the spring is in contact with the housing when in locked position.In combination with high forces applied during the surgery this might have led to the loosening of the locking lever and resulted in disassembling of the rasp handle.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the returned product and the results of the investigation the complaint could be confirmed.However, an exact root cause 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).
Event or Problem Description
Please refer to report 0009613350-2019-00024.

• Brand Name: MIS, RASP HANDLE, DOUBLE OFFSET, RIGHT
• Common Device Name: MIS DOUBLE OFFSET RASP HANDLE, RIGHT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8239179
• Report Number: 0009613350-2019-00024
• Device Sequence Number: 13984725
• Product Code: LXH
• UDI-Device Identifier: 00889024277052
• UDI-Public: 00889024277052
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 01.00001.002
• Device Lot Number: 11666866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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