MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.026

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Reporter is a j&j representative.The device was received, the investigation is in progress, 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 Description

It was reported that on unknown date, patient underwent an orthopedic surgery.It was noted that the triple trocar for tfna head element would not fully connect between the 3 different trocars.During the surgery, the inner connecting screw for the lag screw insertion handle would not fully seat.There was a one-minute of surgical delay noted.There were no fragments generated noted.It is unknown if the procedure was successfully completed.There were no patient consequences.This complaint involves five (5) devices.This report is for (1) helical blade/screw coupling screw.This report is 5 of 8 for (b)(4).

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.Investigation flow: device interaction / functional.Visual inspection: the helical blade/screw coupling screw (p/n: 03.037.026, lot #: l899805) was returned and received at us cq.Upon inspection of the returned device, scratches were observed on the devices.No other issues were identified with the returned device.Device failure/defect was not identified.Functional test: a functional test was performed to assemble the device with the mating instrument.The screw inserter was able to fully assemble with the helical blade/screw coupling screw.Reported condition of unable to assemble could not be confirmed.Can the complaint can not be replicated with the returned devices.Document/specification review: based on the manufactured date, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Dimensional inspection: dimensional analysis was not performed as no damage was identified on the returned device and the device was able to assemble on to the mating device completely without any issues.Complaint was not confirmed.Investigation conclusion: the overall complaint condition could not be confirmed for the returned device as the mating device was able to fully assemble with the alleged returned device.There is no indication that a design or manufacturing issue has caused the issue.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : update by (b)(6) on 27.09.2021.The lot # l899805 does not exist in sap p02.Dhr review cannot be performed.Device history review : a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12460253
• MDR Text Key: 271039230
• Report Number: 2939274-2021-05350
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)10886982070425
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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: 08/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.026
• Device Catalogue Number: 03.037.026
• Device Lot Number: L899805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: 3.2MM WIRE GUIDE SLEEVE; GUIDE SLEEVE YELL; TFNA SCR INSERT; TROCAR YELL; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; 3.2MM WIRE GUIDE SLEEVE; GUIDE SLEEVE YELL; TFNA SCR INSERT; TROCAR YELL; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA