MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 6 HOLES/45MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Model Number 232.069

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2020; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter phone number: (b)(6).The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 Description

It was reported that on (b)(6) 2020, the patient underwent removal of plate and an unknown screws followed by a hindfoot nail procedure due to nonunion and a broken plate and one (1) broken unknown cortex screw.Initially, the patient was implanted with a cannulated angled blade plating system on (b)(6) 2020.It was also reported that there was delayed healing and decreased range of motion.Concomitant devices reported: unknown 3.5 mm cortex screws (part# unknown, lot# unknown, quantity 2).Unknown cancellous screw (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for (1) 3.5mm 90 deg cann lc-angled blade plate 6 holes/45mm.This is report 1 of 2 for (b)(4).

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.Manufacturing location: supplier ¿ (b)(4), packaging and release by: monument, release to warehouse date: december 11, 2006, part number: 232.069, 3.5mm 90 deg cann lc-angled blade plate 6 holes/45mm, lot number: 5346844 (non-sterile), lot quantity: 20.Work order traveler met all inspection acceptance criteria.Certificate of compliance supplied by magnum dated november 16, 2006 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 17003, 316l pi 11.00x3.30, lot number: 4630671, lot quantity: 1,879 lbs.Product traveler met all inspection acceptance criteria.Inspection certificate supplied by sandvik dated july 25, 2003 was reviewed and determined to be conforming.Raw material inspection sheet met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.The device was not returned.A photo-investigation was performed on the images.There were two undated x-rays views; due to the images' angles and surrounding concomitant devices, a broken condition of the plate and screw could not be visualized.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion the complaint condition was not confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 90 DEG CANN LC-ANGLED BLADE PLATE 6 HOLES/45MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10900980
• MDR Text Key: 218204684
• Report Number: 2939274-2020-05290
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982159847
• UDI-Public: (01)10886982159847
• Combination Product (y/n): N
• PMA/PMN Number: K992837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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
• Device Operator: Health Professional
• Device Model Number: 232.069
• Device Catalogue Number: 232.069
• Device Lot Number: 5346844
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/21/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CANCELLOUS; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CANCELLOUS; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR