MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PROX TIBIA PL14 H R; PLATE, FIXATION, BONE

Model Number	02.124.220
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
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.The patient experienced a broken plate and non-union post-operatively requiring revision.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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) 2019, the patient underwent removal of hardware due to malunion and (1) locking compression plate (lcp) proximal tibia broke.There was no surgical delay reported.Procedure was successfully completed.There was no patient consequence reported.Concomitant devices reported: locking screw self-taping with stardrive recess 75mm (part# unknown, lot# unknown, quantity# 1); locking screw self-taping with stardrive recess 60mm (part# unknown, lot# unknown, quantity# 2); locking screw self-taping with stardrive recess 70mm (part# unknown, lot# unknown, quantity# 2); locking screw self-taping with stardrive recess 26mm (part# unknown, lot# unknown, quantity# 1); locking screw self-taping with stardrive recess 24mm (part# unknown, lot# unknown, quantity# 1); locking screw self-taping with stardrive recess 30mm (part# unknown, lot# unknown, quantity# 1); cancellous bone screw fully threaded 26mm (part# unknown, lot# unknown, quantity# 1); cancellous bone screw fully threaded 30mm (part# unknown, lot# unknown, quantity# 1)/ this complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.A review of the device history record revealed no complaint related anomalies.The device history record shows this 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: 3.5MM LCP PROX TIBIA PL14 H R
• 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: 8574744
• Report Number: 2939274-2019-57792
• Device Sequence Number: 19456615
• Product Code: HRS
• UDI-Device Identifier: 10886982042651
• UDI-Public: (01)10886982042651
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 02.124.220
• Device Catalogue Number: 02.124.220
• Device Lot Number: 7774571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANCELLOUS BONE SCREW 26MM; CANCELLOUS BONE SCREW 30MM; LOCKING SCREW 75MM; LOCKING SCREW 24MM; LOCKING SCREW 26MM; LOCKING SCREW 30MM; LOCKING SCREW 60MM; LOCKING SCREW 70MM; UNK - LOCKING SCREW 75MM; CANCELLOUS BONE SCREW 26MM; CANCELLOUS BONE SCREW 30MM; LOCKING SCREW 75MM; LOCKING SCREW 24MM; LOCKING SCREW 26MM; LOCKING SCREW 30MM; LOCKING SCREW 60MM; LOCKING SCREW 70MM; UNK - LOCKING SCREW 75MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR