MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY LAG SCREW REAMER 3.2MM; TRAUMA INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 00249003244, cephalomedullary lag screw reamer long.Lot # unknown.G2: france.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00934.H3 other text : not returned.
Event or Problem Description
It was reported that the surgeon used the long drill bit on the patient and the drill bit fractured on 2 occasions during cephalic aiming.One part of the drill bit was left in the patient because it was impossible to find it, this happened the second time it fractured.There was a delay of 60 minutes and the surgeon followed the proper surgical technique.No additional surgery needed.No further information was known.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 00249003244, cephalomedullary lag screw reamer long.Lot # 64196767.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Proposed code: mechanical (g04)- drill reported event was confirmed as visual examination of the returned products identified cutting edges are dull and damaged and the damage too severe for dimensional analysis.The cutting feature is fractured and missing.Material hardness is conforming to print specifications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left femoral intramedullary rod and gamma nail with fractured drill bit within the femoral head.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY LAG SCREW REAMER 3.2MM
• Common Device Name: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18947287
• Report Number: 0001822565-2024-00953
• Device Sequence Number: 7906232
• Product Code: HSB
• UDI-Device Identifier: 00889024063532
• UDI-Public: (01)00889024063532(10)64035396
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2024

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: 00249003244
• Device Lot Number: 64035396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 06/20/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/22/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Male