MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LC-DCP® PLATE 7 HOLES/90MM; PLATE,FIXATION,BONE

Model Number	223.57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient sex and weight were not provided for reporting.Date of event is unknown.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review is pending completion.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 the patient was initially implanted with one (1) 3.5 mm locking compression plate and six (6) 3.5 mm cortex screws on an unknown date.Patient presented with a non-union and infection.On (b)(6) 2017, a revision surgery of the right tibial shaft was performed.During the revision surgery, all the seven (7) implants were removed.The revision surgery was completed successfully and no new additional devices were implanted.The patient was reported to be in stable condition.This report is for one (1) 3.5mm lc-dcp plate 7 holes/90mm.(b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 27-dec-2000 part #: 223.57, lot#: 4205065 (non-sterile) ¿ 3.5mm lc-dcp plate 7 holes/90mm.Quantity 60.Inspection sheet ¿ in-process inspection and final inspection and for dimensional inspection meet acceptance criteria of inspection sheet.Components: part- 17003, lot: 4011932 reviewed and it meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product 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 LC-DCP® PLATE 7 HOLES/90MM
• 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: 7118592
• Report Number: 2939274-2017-50277
• Device Sequence Number: 16481831
• Product Code: HRS
• UDI-Device Identifier: 10886982157928
• UDI-Public: (01)10886982157928(10)4205065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/16/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 223.57
• Device Catalogue Number: 223.57
• Device Lot Number: 4205065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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