MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 00234702022, cortical bone screw selftapping hex head, lot # 63963923 x 4.Catalog #: 00235901635, 3.5 mm locking screw 16 mm length, lot # 63985493 x 3.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its not being returned by the hospital.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 patient underwent an internal fixation of the right clavicle fracture approximately 9 months ago.Postoperative c-arm fluoroscopy showed that the fracture was in good alignment and line, and the internal fixation position was good.About 5 months ago, patient returned to the hospital for examination and found the pain caused by the fractured plate.Then, approximately 4 months ago the patient was re- operated on to remove the fractured plate due to pain.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as medical records stated that the middle section of the steel plate was broken, the fracture end displaced, hyperplasia of some scar tissues at the fracture end was seen, and some bone defects were seen at the back.Radiographs also noted ap scalp film from a chest ct demonstrates fracture of the plate along its mid aspect.Device history record was reviewed and no discrepancies relevant to the reported event 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12383985
• Report Number: 0001822565-2021-02373
• Device Sequence Number: 3650572
• Product Code: HRS
• UDI-Device Identifier: 00889024104228
• UDI-Public: (01)00889024104228(17)281130(10)64236248
• 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: 2020
• Device Explanted Year: 2021
• 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): 08/23/2021

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: N/A
• Device Catalogue Number: 47493601013
• Device Lot Number: 64236248
• 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: 08/05/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female