MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB DRILL BIT, 4.3 MM, 145 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did receive per, x-rays and implant record for review.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
During surgery the drill bit was fractured inside the bone and surgeon couldn't retrieve it.The broken piece remained in the patient.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
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Harm: tissue damage, minor.Hazard: fragments of a device and/or bone are present in the patient intraoperatively and are not removed before completing implantation.There are 2 intra-operative x-rays available.The x-rays are dated (b)(6) 2021 and show an implanted plating system with some screws, cerclage wires and an existing knee prosthesis.Visual examination: the drill was returned for investigation.The broken piece that stayed in patients' body was not returned.The breakage of the drill can be confirmed.No other damages or deformations can be seen.The product is intended for treatment.The investigation results did not identify a non-conformance 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).

• Brand Name: NCB DRILL BIT, 4.3 MM, 145 MM
• Common Device Name: NCB DRILL BIT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11250781
• Report Number: 0009613350-2021-00050
• Device Sequence Number: 3111256
• Product Code: HTW
• UDI-Device Identifier: 00889024289253
• UDI-Public: 00889024289253
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00024.001
• Device Lot Number: PF15011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: Hospitalization
• Patient Weight: 77