MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.4MM CRUCIFORM SCRWDRVR SHAFT 100MM; SCREWDRIVERS

Catalog Number	03.900.022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device availability is unknown.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.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 a cruciform screwdriver tip broke intraoperatively (b)(6) 2017 during a planned hardware removal of a 2.4 mm screw.The tip fragment was unable to be retrieved and remains implanted.There was no reported delay in the surgery, and no reported harm to the patient.Patient outcome was good.The procedure was a planned hardware removal from the left talus.There was no reported product problem, and the patient was healed.Reported concomitant part: unknown 2.4 mm screw (part # unknown, lot # unknown, qty.1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be 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.
Additional Manufacturer Narrative
(b)(6).A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part number: 03.900.022, synthes lot number: 7731034: release to warehouse date: 13.Feb.2012, manufacturing site: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed.The returned 6 year old 2.4mm cruciform screwdriver shaft (part#03.900.022) is a reusable instrument available for use in the screw removal set to aid in removing depuy synthes screws that have cruciform screw head drive recess geometries.The reported complaint condition of broken is confirmed.A portion of one (1) of the four (4) distal cruciform blades has sheared off and was not returned.The material surface at the fracture site appears homogeneous when viewed under 5x magnification.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The width of the remaining/intact portion of the broken cruciform blade measured at cq and found to be within specification per relevant drawing.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: 2.4MM CRUCIFORM SCRWDRVR SHAFT 100MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7213389
• Report Number: 2939274-2018-50379
• Device Sequence Number: 13749354
• Product Code: HXX
• UDI-Device Identifier: 10886982080677
• UDI-Public: (01)10886982080677(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.900.022
• Device Lot Number: 7731034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/24/2018; 01/25/2018; 02/07/2018; 02/28/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 01/26/2018; 01/30/2018; 02/16/2018; 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR