MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5 VA-LCP MED DSTL TIBIA PL/4 H/LFT; PLATE, FIXATION, BONE

Model Number	02.118.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on (b)(6), 2021, patient underwent a hardware removal and revision correction due to non-union and broken screws.One of five(5) screws 4.0xmm was broken with shaft retained(1) and three of four(4) screws 2.7xmm va locking were broken with shaft retained(3).The procedure was completed successfully without surgical delay.The patient outcome was unknown.Concomitant medical products: ex tibia nail 8x300 mm (part# 04.034.240s; lot# h169638; quantity: 1), unk - screws: 4.0 mm nail locking screw (part# unk; lot # unknown; quantity: 4), plate va medial distal tibia (part# 02.118.003; lot# 894268; quantity: 1), unk - screws: 3.5 mm cortex (part# unknown; lot# unknown; quantity: 4), unk - screws: 2.7 mm va locking (part# unknown; lot# unknown; quantity: 1).This complaint involves four(4) devices.This report is for one (1) 2.7/3.5 va-lcp med dstl tibia pl/4 h/lft.This is report 2 of 12 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device history lot part: 02.118.003, lot: l894268, manufacturing site: raron, release to warehouse date: 15 may 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 2.7/3.5 VA-LCP MED DSTL TIBIA PL/4 H/LFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12698753
• Report Number: 2939274-2021-06293
• Device Sequence Number: 11132836
• Product Code: HRS
• UDI-Device Identifier: 10886982037602
• UDI-Public: (01)10886982037602
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 02.118.003
• Device Catalogue Number: 02.118.003
• Device Lot Number: L894268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8 TI CANN TIBIAL NAIL-EX PROX BEND 300-S; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 2.7 MM VA LOCKING; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW; UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male