MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE HEXAGONAL SCREWDRIVER Ø5 COATED; SCREWDRIVERS

Catalog Number	357.417
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: 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 or Problem 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 1 of 10 for (b)(4).
Additional Manufacturer Narrative
Dhr review part number: 357.417 synthes lot number: 7681052 supplier lot number: 7681052 release to warehouse date: 26-nov-2014 supplier: greatbatch medical manufacturing site: (b)(4) no ncrs were generated during production.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.Customer quality conducted an investigation of the returned device.The flexible hexagonal screwdriver 5mm, coated (357.417) is intended for use to engage the preassembled locking mechanism in titanium trochanteric fixation nails (tfn) to lock the rotation of the head element.The tfn system is intended for the intramedullary fixation of proximal femur fractures.This information is provided per the titanium trochanteric fixation nail system technique guide.The returned device was examined and the complaint condition was unable to be confirmed as no coating was noted on the device¿s handle upon receipt.Whether or not the complaint condition as able to be replicated is not applicable.The device was sterilized prior to receipt which appears to have removed the substance.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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: FLEXIBLE HEXAGONAL SCREWDRIVER Ø5 COATED
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7382449
• Report Number: 2939274-2018-51307
• Device Sequence Number: 16448044
• Product Code: HXX
• UDI-Device Identifier: 10886982196408
• UDI-Public: (01)10886982196408(10)UNKNOWNLOTNUMBER
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 357.417
• Device Lot Number: 7681052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1