MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STN PN THD TIP .125X2.5IN 2PK; SURGICAL INSTRUMENT

Model Number	406669
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
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 fractured piece is retained in the patient's body.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 the tip of the drill pin broke off in the shoulder during the procedure.No additional patient consequences were reported.
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/corrected: b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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: STN PN THD TIP .125X2.5IN 2PK
• Common Device Name: SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12476256
• Report Number: 0001825034-2021-02674
• Device Sequence Number: 5760116
• Product Code: LXH
• UDI-Device Identifier: 00887868505232
• UDI-Public: (01)00887868505232
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 406669
• Device Catalogue Number: 406669
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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: Required Intervention