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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.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.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
(b)(6) reported that during an open reduction internal fixation (orif) of a proximal femur using a trochanteric fixation nail (tfn) instrumentation, the staff noticed what appeared to be greasy residue on the underside of the handle of a flexible hexagonal screwdriver coated.It was put aside and another tray was opened, but the instrument of the same part number was opened with the same issue.A third tray was opened with no issues and the procedure was completed without further problems or patient harm.There was no surgical time delay reported.No additional information is available.This is report 1 of 2 for complaint (b)(4).
Additional 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.Part: 357.417, lot: 7681060: release to warehouse date: march 06, 2015.Supplier: greatbatch medical/orvin/switz.Manufactured by synthes.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was completed: per the technique guide, 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.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.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 material review reports (mrrs), non-conformance repots (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: 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: 7378795
• Report Number: 2939274-2018-51281
• Device Sequence Number: 1097591
• 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: 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: 7681060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1