MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR SMALL SCREWS

Model Number 319.09

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j sales 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, during a routine incoming inspection of the loaner set at fsl ups lyndhurst, nj site, it was observed that the depth gauge was bent.There was no patient involvement.This complaint involves one (1) device.This report is for (1) depth gauge for small screws.This report is 1 of 1 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 summary: background: it was reported that on an unknown date, during a routine incoming inspection of the loaner set at fsl ups lyndhurst, nj site, it was observed that the depth gauge was bent.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the depth gauge for small screws (p/n: 319.090, lot number: 8254887) was received at us cq.Visual inspection of the complaint device showed the shaft was bent.Device failure/defect was identified.Service and repair evaluation: the customer reported the device was bent.The repair technician reported bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: se_490644 rev c (current) and se_182576 rev a (manufactured) were reviewed.No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as the shaft was bent.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 history lot: part: 319.090.Lot: 8254887.Manufacturing site: bettlach.Release to warehouse date: 19 feb 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: DEPTH GAUGE FOR SMALL SCREWS
• Type of Device: GAUGE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11902288
• MDR Text Key: 267169118
• Report Number: 2939274-2021-02664
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189998
• UDI-Public: (01)10886982189998
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.09
• Device Catalogue Number: 319.09
• Device Lot Number: 8254887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1