MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCRDRIVER-HEX W/SPHERIC-HEAD Ø8; SCREWDRIVERS

Catalog Number 03.010.092

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Product code: grease was found on the underside of the identified item.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 while nurses setting up to perform a tfn procedure noticed that there was a thin translucent layer of grease on the underside of item 357.417 and also on the underside of item 03.010.092.Then they put these trays to the side and proceeded to open 8 additional trays of tfn instruments for a total of 10 trays that were opened, all of which the grease was found on the underside of the identified items each time, for a total of 10 affected items.Five of the 357.417 and five of the 03.010.092.The surgery was completed using a similar set of instruments from a competitor.There was no delay in surgery time.There was no patient impact.This is report 9 of 10 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.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: SCRDRIVER-HEX W/SPHERIC-HEAD Ø8
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7382484
• MDR Text Key: 104044051
• Report Number: 2939274-2018-51328
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982067630
• UDI-Public: (01)10886982067630(10)UNKNOWNLOTNUMBER
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1