MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, DF DRILL BIT, 4.3, LENGTH 300 MM; TRAUMA 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not 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 or Problem Description
It was reported that a fractured instrument was returned to a local warehouse.The following details are unknown, patient involvement, if a surgery took place , the number of times the device has been used previously.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Reported event: it was reported that a fractured instrument was returned to the local warehouse.No further due diligence required as all required information to support the conclusion is available or was already requested.Harm: no patient, user, or other stakeholder harm.Hazard: device not used for implantation due to non-functionality or visible damages.No relevant medical data has been received.Visual examination: the drill bit was received for investigation.The visual examination confirms the breakage of the device.It can be assumed that the drill was broken due to high forces applied on the instrument.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 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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB, DF DRILL BIT, 4.3, LENGTH 300 MM
• Common Device Name: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12286433
• Report Number: 0009613350-2021-00387
• Device Sequence Number: 11863794
• Product Code: HTW
• UDI-Device Identifier: 00889024289277
• UDI-Public: 00889024289277
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: N/A
• 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): 08/25/2021

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: 02.00024.003
• Device Lot Number: 4504074153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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
• Outcome Attributed to Adverse Event: Other