MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS; GAUGE, DEPTH

Model Number 03.111.005

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been 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 (b)(6) 2020, the patient underwent an open reduction internal fixation (orif) of a right distal radius.During the procedure, it was noticed that the depth gauge was sticking.The depth gauge was bent and that was causing it to stick.It is unknown if there was any surgical delay.The surgery was successfully completed with no surgical delay.The patient outcome was good.This report involves one (1) depth gauge for 2.0 mm/2.4 mm and 2.7 mm screws.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.H3, h6: investigation summary.Investigation flow: damage.Visual inspection: the depth gauge for 2.0mm/2.4mm and 2.7mm screws (p/n: 03.111.005, lot number: 10-1965) was received at us cq.Upon visual inspection, it was noticed that the needle component is bent.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the needle component is bent.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: 03.111.005, lot: 10-1965, manufacturing site: selzach , supplier: (b)(4), release to warehouse date: feb 23, 2010.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 2.0MM/2.4MM AND 2.7MM 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: 10482202
• MDR Text Key: 209817421
• Report Number: 2939274-2020-03909
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072078
• UDI-Public: (01)10886982072078
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.111.005
• Device Catalogue Number: 03.111.005
• Device Lot Number: 10-1965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 54