MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 7 HOLES 98MM; PLATE, FIXATION, BONE

Model Number	223.571
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient age not reported.It is unknown when the non-union occurred; unknown date in 2016 or 2017.Device is not expected to return.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a revision surgery was performed on (b)(6) 2017 due to non-union of a ulna bone.The original surgery date occurred on (b)(6) 2016 due to a forearm fracture.All previously implanted hardware was removed intact and included a 3.5 mm lcp plate 7 holes and 6 (3.5 mm cortex screws).The patient was revised to a 9 hole lcp plate with 8 (3.5 mm cortex screws).The surgery was completed successfully with no delays.Patient outcome was noted as stable.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 7 HOLES 98MM
• 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: 7151681
• Report Number: 2939274-2017-50473
• Device Sequence Number: 1485296
• Product Code: HRS
• UDI-Device Identifier: 10886982157935
• UDI-Public: (01)10886982157935(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 223.571
• Device Catalogue Number: 223.571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 180