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

Model Number	110005315
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as hospital discarded the product.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 after the surgeon had deployed the implant into the patient's bone and placed tension on the sutures, the sutures fractured from the implant.The implant was retained by the patient and there are no further plans for a revision surgery to remove the foreign body from the patient.The procedure was completed with another device.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: JGRKNT SHORT RIGID SZ2 IMP/DRL
• Common Device Name: FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINCE
• 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: 17117410
• Report Number: 0001825034-2023-01308
• Device Sequence Number: 7200429
• Product Code: MBI
• UDI-Device Identifier: 00880304568204
• UDI-Public: (01)00880304568204(17)261127(10)0002402372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 110005315
• Device Catalogue Number: 110005315
• Device Lot Number: 0002402372
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male