MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER, HANDLE FOR RASP; N/A

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item # 0104236600, item name anatomical shoulder, handle for rasp, straight, lot # 11607305.The manufacturer did not receive x-rays, or 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 that during surgery, handle came off loose when rasp was knocked out.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, d10, g4, g7, h3, h10.Investigation and conclusion harm: no patient, user, or other stakeholder harm.No further due diligence required as all required information to support the conclusion is available/was already requested.No relevant medical data has been received.Visual examination: the two rasps show several signs of usage.The opening mechanism is slightly loose.The products are intended for treatment.The investigation results did not identify a non-conformance or a complaint out of box (coob).The instruments where manufactured in 2011 and 2013 and have therefore been in use for several years.Therefore the most likley root cause is a deterioration in function during long term use.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
No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER, HANDLE FOR RASP
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8959442
• Report Number: 0009613350-2019-00554
• Device Sequence Number: 2562467
• Product Code: LXH
• UDI-Device Identifier: 00889024286429
• UDI-Public: 00889024286429
• 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): 06/24/2020

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: 01.04233.000
• Device Lot Number: 13.878179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 06/24/2020
• 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