MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 HOLES/RIGHT; PLATE,FIXATION,BONE

Model Number	02.118.208S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hwc.Complainant device 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 that a hardware removal and revision open reduction internal fixation (orif) was performed on (b)(6) 2017 due to tibia non-union and a broken plate.The original procedure was performed on (b)(6) 2017.Subsequently it was discovered that the plate had broken and there was a fracture non-union.It is noted that the patient is (b)(6), and was likely non-complaint with post-operative non-weight bearing instructions.Removed hardware included: one broken plate and ten screws.All hardware was removed intact except for one 2.7mm locking screw, which broke at the head during removal.As the surgeon went to remove the screw, the head snapped off.The screw shaft fragment was left in the patient¿s bone.The patient was revised to another plate and screws with autograft and allograft bone.There was no reported surgical delay, no additional x-rays or other medical intervention required.The procedure was completed successfully with the patient in stable condition.Concomitant parts reported: 2.7 mm locking screws (part # unknown, lot # unknown, quantity 1), 2.7 mm va locking screws (part # unknown, lot # unknown, quantity 5), 3.5 mm locking screws (part # unknown, lot # unknown, quantity 1), 3.5 mm cortex screws (part # unknown, lot # unknown, quantity 1).This report addresses the hardware removal and revision due to tibia non-union and a broken plate.The intraoperative broken screw has been captured under linked complaint (b)(4).This report is for one (1) 2.7/3.5mm va-lcp anterolateral distal tibia pl/10 holes/right.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part# 02.118.208, lot# 9873635: date of manufacture: 10 august 2015, place of manufacture: (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 2.7/3.5mm va-lcp anterolateral distal tibia pl/10 holes/right 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.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: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 HOLES/RIGHT
• 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: 7134676
• Report Number: 2939274-2017-50384
• Device Sequence Number: 16164662
• Product Code: HRS
• UDI-Device Identifier: 10886982038432
• UDI-Public: (01)10886982038432(10)9873635
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.118.208S
• Device Catalogue Number: 02.118.208
• Device Lot Number: 9873635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: 94