MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/7H/LT/120MM; PLATE, FIXATION, BONE

Model Number	02.112.093
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, patient had surgery to install a synthes 3.5 mm lc-dcp variable angle clavicle plate on his left clavicle after a cycling crash that left him with a severe break.On (b)(6) 2021, as he was reaching up, he heard a pop and immediate sharp pain, followed by consistent dull aching pain for weeks.He went to see an orthopedic surgeon on (b)(6) 2021, where they took an x-ray, it looked like the plate had broken.He was sent for a ct scan on (b)(6) 2021 to further confirm that it, in fact, was broken.He then had a second surgery on (b)(6) 2021 to remove the broken hardware and install a new plate.There is no further information available.This report is for one (1) 3.5mm lcp superior clavicle plate w/lat extn/7h/lt/120mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6- the complaint device was not received for investigation.A photo investigation was performed implant photograph.Examination of the provided product photograph found the reported clavicle plate is broken in two pieces.The investigation found sufficient evidence to confirm the broken event reported.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection document/specification review were not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM LCP SUPERIOR CLAVICLE PLATE W/LAT EXTN/7H/LT/120MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12909894
• Report Number: 2939274-2021-06884
• Device Sequence Number: 5085156
• Product Code: HRS
• UDI-Device Identifier: 10886982033277
• UDI-Public: 10886982033277
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111540
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 02.112.093
• Device Catalogue Number: 02.112.093
• Device Lot Number: 02.112.093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 12/18/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING: LCP CLAVICLE PLATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 81 KG