MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH

Catalog Number 319.004

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.It is unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Reporter phone number is not available for reporting.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 a depth gauge was found broken after the tray was sent through sterile processing department on (b)(6) 2018.There was no procedure and patient involvement.This is report 1 of 1 for complaint (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, h4, h6: device history records review was completed for part# 319.004, lot# ft00317.Supplier (b)(4) , release to warehouse date: feb 17, 2017.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.H3, h6: product investigation was completed.Visual inspection performed observed the returned depth gauge was broken at its needle distal tip portion.The broken tip portion was not returned.It was also observed that the protection sleeve component was not returned.The remainder of the needle is bent in several areas and directions.The returned device condition agrees with the complaint description and therefore the complaint was confirmed.Relevant drawings for the returned instrument were reviewed during this investigation.The 319.004 depth gauge is a reusable instrument intended for use in measuring for 1.3mm and 1.5mm screws in various plating systems and is listed in techniques guides for headless compression screws, the modular hand system, and the rotation correction plate system.No product design issues or discrepancies were observed.A dimensional inspection near the broken region was not able to be performed because of the post manufacturing damage.The diameter of the needle just proximal to the breakage and bends measured ø0.96mm (calipers ca215p) which is within the specification of ø1.0mm -0.07/-0.02mm per needle component drawing.The design specified the needle to be manufactured from 316leh stainless steel per needle component drawing.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted in the device history records.A definitive root cause for the needle breaking and bending could not be determined based on the provided information.However, it is possible that breakage could be because of unintended forces on the device during its routine usage/ sterile processing.It was observed that the protection sleeve (primary function to protect the needle from damage) is missing/was not returned.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 1.3MM AND 1.5MM 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: 7865064
• MDR Text Key: 119936449
• Report Number: 2939274-2018-53734
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936
• 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: 08/23/2018

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: 319.004
• Device Lot Number: FT00317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1