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

Catalog Number 319.09

Device Problems Use of Device Problem (1670); Material Deformation (2976)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.: 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 on (b)(6) 2021, the depth gauge tip was bent and was missing a screw.It was unknown when the issue was discovered.Patient and procedure involvement are unknown.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

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.H3, h6: a product investigation was conducted.Visual inspection: the depth gauge for small screws (p/n: 319.09, lot #: 5340061) was returned and received at us cq.Upon visual inspection, it was observed that the device tip is bent and knurled cap is missing.No other issues were observed with the returned device.Dimensional inspection: there was conclusive evidence that the returned device was missing components and the damage is post manufacturing defect so the dimensional inspection was not performed.Service and repair evaluation: the customer reported on march 23, 2021, the depth gauge tip was bent and was missing a screw.The repair technician reported tip is bent and knurled cap is missing.Damaged component 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.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed yes, the tip of the device was bent and knurled cap was missing.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the depth gauge for small screws (p/n: 319.09, lot #: 5340061).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.H3, h4, h6: a device history record (dhr) review was conducted: part no: 319.09, supplier lot: 5340061, date of manufacture: 9/15/2006, no ncs were found related to this lot.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

The reported issue was discovered during inspection.There was no patient involvement.

• Brand Name: DEPTH GAUGE FOR SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12184732
• MDR Text Key: 262254383
• Report Number: 2939274-2021-04143
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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 Catalogue Number: 319.09
• Device Lot Number: 5340061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1