MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER, REVERSE, DRILL FOR GLENOID; N/A

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional 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.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 tha during surgery the supporting pins of drill were broken.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Visual examination: it can be confirmed that the two pins at the connection shaft of the instrument have fractured off.The product is intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).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 0009613350-2019-00383.

• Brand Name: ANATOMICAL SHOULDER, REVERSE, DRILL FOR GLENOID
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8694484
• Report Number: 0009613350-2019-00383
• Device Sequence Number: 1942054
• Product Code: KWS
• UDI-Device Identifier: 00889024287464
• UDI-Public: 00889024287464
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N/A
• 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): 02/21/2020

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: 01.04239.140
• Device Lot Number: 14.045377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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