MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE,DEPTH

Catalog Number 319.091

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: there was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.

Event Description

It was reported that on an unknown date, it was identified in the sterile processing department that the screwdriver would not mate with the handle.The sales rep further described that the inner workings were broken.Apart from this, the little bearing fell out of the depth gauge and this might cause the depth gauge to fall quickly on the floor.There was no procedure or patient involvement.Concomitant device reported: unknown handle (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This complaint is for one (1) depth gauge for 3.5mm cortex screws.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Dhr review was completed.Part number: 319.091.Synthes lot number: ft00441.Supplier lot number: ft00441.Release to warehouse date: (b)(6) 2017.Manufacturing site: (b)(4).Supplier: (b)(4).No ncrs were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Concomitant device previously reported is not concomitant and has been added as an impacted product to this complaint.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 3.5MM CORTEX 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: 7935601
• MDR Text Key: 122816749
• Report Number: 2939274-2018-54161
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982190000
• UDI-Public: (01)10886982190000
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.091
• Device Lot Number: FT00441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1