MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.0 MM THREADED PIN; INSTRUMENT, SURGICAL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned threaded pin noted fracture at the junction of the threads and the threaded portion was not returned.Additional analysis of the returned piece showed suspected crack exit site and indications of torsional overload.Device history record (dhr) was reviewed and no discrepancies were found.Per the surgical technique, a caution is listed to retighten the connected bolt to the nail to maintain targeting accuracy.It was mentioned that the guide had become loose during impaction and was misaligned, resulting in the pin hitting the nail during drilling and led to product failure.The root cause has been determined to be user error.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.Concomitant medical products: 00249000801, antegrade femoral connecting bolt small, lot # 63991880.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03079.
Event or Problem Description
It was reported that during a procedure, when the surgeon was drilling a 3 mm threaded pin, the threaded tip fractured off in the patient's proximal femur after binding against the nail.The surgeon decided to leave the fragment in situ.The surgeon determined that the targeting guide was slightly loose, causing the guide pin to be misaligned and hit the nail.Attempts have been made and no further information has been provided.

• Brand Name: 3.0 MM THREADED PIN
• Common Device Name: INSTRUMENT, SURGICAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9538603
• Report Number: 0001822565-2020-00009
• Device Sequence Number: 16715208
• Product Code: FZX
• UDI-Device Identifier: 00889024063921
• UDI-Public: (01)00889024063921
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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: 00249004630
• Device Lot Number: 64205351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR