MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP X-ARTICLR PROXIMAL ULNA PL 8H/RT/157MM; PLATE, FIXATION, BONE

Model Number	02.107.408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient weight not available for reporting.Date infection began is not known.Date of implant reported as approximately 6 months prior to removal.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.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 patient was implanted with a 2.7mm/3.5mm variable angle locking compression plate (va lcp) extra-articular proximal ulna plate approximately 6 months prior to removal.Patient presented with pus drainage from the incision and was returned to surgery on (b)(6) 2017 where surgeon removed the va lcp extra-articular proximal ulna plate, three (3) 3.5mm cortical screws, two (2) 3.5mm locking screws, and six (6) 2.7mm va locking screws.Patient was revised to antibiotic beads.Procedure was completed successfully with no delay.(b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part# 02.107.408, lot# 6924100, part mfg date: 20 april 2012, mfg location: (b)(4) synthes, part expiration date: n/a , nonconformances noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm va-lcp x-articular proximal ulna plate 8h/rt/157mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 8H/RT/157MM
• 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: 7155176
• Report Number: 2939274-2017-50500
• Device Sequence Number: 11228324
• Product Code: HRS
• UDI-Device Identifier: 10886982029423
• UDI-Public: (01)10886982029423(10)6924100
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.107.408
• Device Catalogue Number: 02.107.408
• Device Lot Number: 6924100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR