MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ASSEMBLY PIN; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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: one end of tip of assembly pin broke off when trying to tighten bolt.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that one end of the assembly pin broke off when trying to tighten a bolt.No pieces fell into the patient and there was no delay.Harm: s1 - no patient, user, or other stakeholder harm hazardous situation: instrument breaks, diverges or becomes damaged and non-functional during surgical procedure.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified the following deviations and/or anomalies: ncr (b)(4).Ncr(s): no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that one end of the assembly pin broke off when trying to tighten a bolt.No pieces fell into the patient and there was no delay.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: ASSEMBLY PIN
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12934195
• Report Number: 0009613350-2021-00646
• Device Sequence Number: 2098390
• Product Code: LXH
• UDI-Device Identifier: 00889024288713
• UDI-Public: 00889024288713
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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: 02.00002.001
• Device Lot Number: 13.867170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown