MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT 12 HOLES 157 MM LENGTH; SCREW, FIXATION, BONE/TRAUMA

Catalog Number	47493601213
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: unknown, unknown locking screw; lot#: unknown; quantity: 11.G2: foreign: china.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was not returned by the patient.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 a patient underwent an initial right ulna orif surgery four years ago.Subsequently, the patient approximately a year and a half ago reported sudden pain in their right arm and the implant had fractured in left right forearm.The patient underwent a revision surgery approximately two weeks later and the fractured implant was explanted and a new implant was implanted into the patient's right arm.
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.Visual examination of the provided pictures identified two pieces of the fractured plate, as well as 4 screws used in fixation.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The product hold associated with this lot is for an incorrect taper angle on the screw thread forms.The fractured plate in this complaint broke between two screw holes, so the thread taper angle would not be related to the reported event.Additionally, the screw hole near the fracture did not have a screw in it when the device fractured.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: interval placement of a plate and screw fixation device and bone graft material involving the proximal ulnar diaphysis with the metal fracture of the plate and revision.Overall fit and alignment of the original ulnar plate is appropriate.Bone graft material is seen.No signs of loosening.Fractured ulnar plate noted.Incomplete healing of the bone graft is.Suspected.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: 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT 12 HOLES 157 MM LENGTH
• Common Device Name: SCREW, FIXATION, BONE/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17550513
• Report Number: 0001822565-2023-02171
• Device Sequence Number: 6854365
• Product Code: HWC
• UDI-Device Identifier: 00889024104266
• UDI-Public: (01)00889024104266(17)280731(17)64102138
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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 Catalogue Number: 47493601213
• Device Lot Number: 64102138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female