MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM; PLATE,FIXATION,BONE

Model Number	02.112.047
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 patient underwent a revision procedure due to a broken va-lcp anterior clavicle plate.During the revision procedure, the reported plate was removed along with the three (3) unknown 3.5mm cortex screws and three (3) unknown 2.7mm cortex screws.The patient was then revised to a new va-lcp anterior clavicle plate.The procedure was successfully completed without a surgical delay.Patient status is unknown.Concomitant device reported: unknown 3.5mm cortex screws (part # unknown, lot # unknown, quantity 3).2.7mm cortex screws (part # unknown, lot # unknown, quantity 3).This complaint involves one (1) device.This report is for (1) 2.7mm/3.5mm va-lcp lat ant clavicle plate/10 hole/101mm this report is 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.H6: photo investigation: the device was not returned.A photo-investigation was performed on the received image.It was observed the plate was broken.No other issues were noted.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion the complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM
• 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: 11021426
• Report Number: 2939274-2020-05614
• Device Sequence Number: 11861177
• Product Code: HRS
• UDI-Device Identifier: 10886982033031
• UDI-Public: (01)10886982033031
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K101536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 02.112.047
• Device Catalogue Number: 02.112.047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 12/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR