MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Model Number 03.010.430

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is jnj 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 an unknown date, the handle for protection sleeves for suprapatellar was not functional before the case started.The retention knob (black knob) on top of the handle for protection sleeve is broken and not able to function properly.There was no patient involvement.This complaint involves one (1) device.This report involves one (1) handle for protection sleeves for suprapatellar.This is report 1 of 1 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.Part number: 03.010.430, lot number: t982288, manufacturing site: tuttlingen, release to warehouse date: december 22, 2012.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the handle for protection sleeves for suprapatellar (p/n: 03.010.430, lot number: t982288) was received at us customer quality cq.Visual inspection of the complaint device showed the knob shaft was bent.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage and inaccessibility of internal components.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the knob shaft is bent which could render the device non-functional.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 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.D9: date device returned to manufacturer.

• Brand Name: HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11219618
• MDR Text Key: 228448024
• Report Number: 2939274-2021-00431
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068712
• UDI-Public: (01)10886982068712
• Combination Product (y/n): N
• PMA/PMN Number: K111667
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.430
• Device Catalogue Number: 03.010.430
• Device Lot Number: T982288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1