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

Model Number 223.571

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7151681
• MDR Text Key: 95949060
• Report Number: 2939274-2017-50473
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982157935
• UDI-Public: (01)10886982157935(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 223.571
• Device Catalogue Number: 223.571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 180