MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item # 00-2490-064-43; calibrated drill 4.3 mm short; lot # unknown.Report source: foreign: event occurred in (b)(6).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: 0001822565-2019-04891.Product not returned.
Event or Problem Description
It was reported that during surgery, the femoral nail was explanted immediately after the implantation as the drill interfered while drilling the descending proximal screw hole.Subsequently, the tip of the drill was fractured inside the patient.The fractured part was able to removed from the patient.The surgery was completed with an alternative nail.It was noticed after the surgery that the right nail had holes for the left.No additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual inspection of the returned product noted holes are machined in an incorrect orientation in relation to the nail.The drill was not returned to perform additional evaluation.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.The incorrect orientation of the holes in the nail lead to the drill bit interference with the nail and fracturing.The root cause is determined as a manufacturing deficiency.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GREATER TROCHANTER FEMORAL NAIL
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9411231
• Report Number: 0001822565-2019-04887
• Device Sequence Number: 2966472
• Product Code: HSB
• UDI-Device Identifier: 00889024096110
• UDI-Public: (01)00889024096110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 47249236013
• Device Lot Number: 63948458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 43