MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER COATED; SCREWDRIVERS

Catalog Number	357.417
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.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.(b)(4) is used to capture the no patient involvement.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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported by the sales consultant that when the medical device reprocessing (mdr) staff was checking the devices before the surgery on (b)(6) 2018, they discovered a small thin amount of translucent grease underneath the handles of seven ball hex screwdriver 8mm, seven hexagonal screwdriver, five stardrive screwdriver t25/self-retaining and three 5.0mm flexible hexagonal screwdriver coated.All these screwdrivers were the parts of two tfn locking trays, two tfn insertion trays, two expert tibial nail sets and two expert retrograde/anterograde femoral nail sets.All these items were quarantined and none of them were used in the surgery.There was no patient or procedure involved.This report addresses eight (8) devices; remaining fourteen (14) devices are captured in complaint files (b)(4).This is report 6 of 8 for complaint (b)(4).

• Brand Name: 5.0MM FLEXIBLE HEXAGONAL SCREWDRIVER 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: 7382668
• Report Number: 2939274-2018-51331
• Device Sequence Number: 1608054
• Product Code: HXX
• UDI-Device Identifier: 10886982196408
• UDI-Public: (01)10886982196408(10)LOTNUMBERUNKNOWN
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• 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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1