MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PIN 2.5 MM DIAMETER; PIN, FIXATION

Model Number	47-4309-025-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the procedure the tip of the pin fractured off.The fractured piece was retrieved from the patient's body.No adverse event has been reported as a result of the malfunction.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 reported event was confirmed by review of provided picture of device.Visual examination of the received picture identified the product was fractured.Device history record (dhr) was reviewed and no discrepancies 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PIN 2.5 MM DIAMETER
• Common Device Name: PIN, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11901019
• Report Number: 0001822565-2021-01468
• Device Sequence Number: 3542733
• Product Code: HSD
• UDI-Device Identifier: 00889024274273
• UDI-Public: (01)00889024274273(17)300727(10)64807541
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 47-4309-025-01
• Device Catalogue Number: 47430902501
• Device Lot Number: 64807541
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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