MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT SHORT RIGID SZ2 IMP/DRL; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	110005315
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I was reported that during the surgery, the inserter of the device fractured.The fractured piece of the inserter was retained by the patient.There is no plan for a revision surgery to remove the foreign body at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital disposed of the product as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d6a.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.D6a: as the device involved is considered an instrument in this event, implant date does not apply.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.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 is available at the time of this report.

• Brand Name: JGRKNT SHORT RIGID SZ2 IMP/DRL
• Common Device Name: FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18494897
• Report Number: 0001825034-2024-00094
• Device Sequence Number: 6991029
• Product Code: MBI
• UDI-Device Identifier: 00880304568204
• UDI-Public: (01)00880304568204(17)261228(10)0002402380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 06/04/2024

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 Catalogue Number: 110005315
• Device Lot Number: 0002402380
• Was Device Available for Evaluation?: No
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown