MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP CLAVICLE HOOK PL 5H 12MM HOOK DEPTH/59MM/RT-STER; PLATE, FIXATION, BONE

Model Number	241.082S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.The narrative could not be confirmed from the provided picture.Due to the quality of the picture the reported problem could not conclusively be confirmed.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) 2020, the locking compression plate (lcp) clavicle hook plate broke at the proximal end.The patient fractured at the medial end of the lcp clavicle hook plate.The patient needed a longer plate.The procedure outcome is unknown.Concomitant device reported: unk - screws: (part # unknown; lot # unknown; quantity: 5).This report is for one (1) 3.5mm lcp clavicle hook pl 5h 12mm hook depth/59mm/rt-ster.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data-g5 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 CLAVICLE HOOK PL 5H 12MM HOOK DEPTH/59MM/RT-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9632704
• Report Number: 2939274-2020-00420
• Device Sequence Number: 16997739
• Product Code: HRS
• UDI-Device Identifier: 10886982165770
• UDI-Public: (01)10886982165770
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K061753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 241.082S
• Device Catalogue Number: 241.082S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention