MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 12 HOLES 163MM; PLATE, FIXATION, BONE

Model Number	223.621
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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) 2020, the patient underwent a removal and revision of fracture, due to nonunion, a broken locking compression plate (lcp) tibial plate and four (4) broken screws.Originally, the patient was implanted with the locking compression plate (lcp) tibial plate in (b)(6) of 2019 at another facility.There were fragments generated from a broken device.The broken shafts had to be trephined but were removed without difficulty.The procedure was completed with no surgical delay.The patient status was stable.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity# 2).This report is for one (1) 3.5mm lcp plate 12 holes 163mm.This is report 1 of 5 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.H11: b1, b5, h1, h6: the initial complaint was reviewed and found not reportable.It was further reported the plate was not broken.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
The initial complaint was reviewed and found not reportable.It was further reported the plate was not broken.

• Brand Name: 3.5MM LCP PLATE 12 HOLES 163MM
• 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: 9716563
• Report Number: 2939274-2020-00864
• Device Sequence Number: 10845130
• Product Code: HRS
• UDI-Device Identifier: 10886982158031
• UDI-Public: (01)10886982158031
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 223.621
• Device Catalogue Number: 223.621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77