MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP X-ARTICLR PROXIMAL ULNA PL 6H/RT/131MM; PLATE, FIXATION, BONE

Model Number	02.107.406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when plate broke; unknown date in 2018.Additional procode: hwc date of implantation is unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is same as date of implantation; unknown date in (b)(6) 2018.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and 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.(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) 2018, the patient underwent a revision due to the broken implanted variable angle (va) locking compression plate (lcp) extra articular proximal ulna plate and non-healing fracture.The plate was implanted around (b)(6) 2018.The plate was removed, the area was bonegrafted and the bone was replated.Surgical outcome and patient outcome is unknown.Concomitant device: trauma screws (part: unknown, lot: unknown, quantity: unknown) this report is for a 2.7mm/3.5mm va-lcp x-articlr proximal ulna pl 6h/rt/131mm.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.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 X-ARTICLR PROXIMAL ULNA PL 6H/RT/131MM
• 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: 7747117
• Report Number: 2939274-2018-53173
• Device Sequence Number: 16534313
• Product Code: HRS
• UDI-Device Identifier: 10886982029409
• UDI-Public: (01)10886982029409
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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: 02.107.406
• Device Catalogue Number: 02.107.406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/28/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE DESCRIPTION, THERAPY DATE: (B)(6) 2018; SEE DESCRIPTION, THERAPY DATE: (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention