MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/LT-STER; PLATE,FIXATION,BONE

Model Number	02.118.207S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.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 one (1) broken 2.7/3.5 mm variable angle locking compression plate (va-lcp) anterolateral distal tibia plate, one (1) broken 3.5 mm cortex screw and nonunion caused a patient to undergo revision of initially implanted devices to a tibial nail on (b)(6) 2018.The initial construct of one (1) 2.7/3.5 mm va-lcp anterolateral distal tibia plate with five (5) locking screws and three (3) proximal cortex screws were implanted in the distal tibia along with one (1) 3.5 mm lcp recon plate with three (3) 3.5 mm cortex screws and one (1) 3.5 mm locking screw were implanted in (b)(6) 2017.Subsequently, the patient developed a nonunion, and the 2.7/3.5 mm va-lcp anterolateral distal tibia plate and one (1) 3.5 mm cortex screw that was attached to the 3.5 mm lcp recon plate broke.The entire construct was removed successfully, including the shaft of the broken 3.5 mm cortex screw that was beneath the recon plate.The patient was then implanted with one (1) unknown tibial nail through a suprapatellar approach and an open reduction internal fixation of the fibula was performed to treat the nonunion and the fracture.The revision procedure was completed successfully, without any complications, or surgical delay.Multiple x-rays were taken during the revision procedure.The patient was reported to be in stable condition.This complaint involves two (2) devices.Concomitant devices reported: 2.7 mm va locking screw (part# 02.211.044, lot# unknown, quantity# 2); 2.7 mm va locking screw (part# 02.211.048, lot# unknown, quantity# 2); 2.7 mm va locking screw (part# 02.211.024, lot# unknown, quantity# 1); 3.5 mm cortex screw (part# 204.828, lot# unknown, quantity# 1); 3.5 mm cortex screw (part# 204.824, lot# unknown, quantity# 1); 3.5 mm cortex screw (part# 204.830, lot# unknown, quantity# 2); 3.5 mm cortex screw (part# 204.826, lot# unknown, quantity# 1); 3.5 mm recon plate (part# 241.081).This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 02.118.207s, lot# h189012.Manufacturing location: (b)(4), manufacturing date: oct 04, 2016, expiry date: aug 31, 2026.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 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/8 H/LT-STER
• 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: 7211559
• Report Number: 2939274-2018-50367
• Device Sequence Number: 11018666
• Product Code: HRS
• UDI-Device Identifier: 10886982038418
• UDI-Public: (01)10886982038418(17)EXPIRYDATEUNKNOWN(10)H189012
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2018

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 Expiration Date: 08/31/2026
• Device Model Number: 02.118.207S
• Device Catalogue Number: 02.118.207S
• Device Lot Number: H189012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 01/26/2018
• 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 Age: 57 YR
• Patient Weight: 73