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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.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)(6).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
It was reported that on (b)(6) 2018, the flexible hexagonal screwdriver in the trochanteric fixation nail set broke while trying to unscrew an internal locking mechanism.It was unknown if there were patient and procedure involved.This report is for a 5.0mm flexible hexagonal screwdriver.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part number: 357.417; synthes lot number: 7789051; supplier lot number: n/a; release to warehouse date: (b)(6) 2015; expiration date: n/a; supplier: (b)(4).No nonconformance records (ncrs) were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.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.It was reported that on (b)(6) 2018, the flexible hexagonal screwdriver in the trochanteric fixation nail set broke while trying to unscrew an internal locking mechanism.It was unknown if there were patient and procedure involved.Flow: broken.The 5mm hex screwdriver (part # 357.417, lot # 7789051, mfg 17-jul-2015) was received at us customer quality (cq) with the flexible shaft of the screwdriver bent in a couple places.There were no visual signs of wear or anything broken.It was determined that the received condition does not agree with the complaint description as the device is not broken (2 or more pieces) as reported.However, the device is bent in a couple places.Thus, the overall complaint is confirmed.Dimensional analysis was completed, the shaft diameter measured 5.77 mm.This is within specification of 5.65 to 5.85 mm, based on design drawing.The measurement c-c across the flats of the tip of the screwdriver measured 4.95 mm.This is within specification of 4.95 mm ± 0.05.The diameter of the flexible portion of the shaft measured 14.57 mm before the first bend (proximal to the tip), 14.62 mm in between the two bends, and 14.34 mm after the second bend.This is within specification of 15 mm ± 0.8 per drawing.All measurements were taken using caliper ca215p and performed on the intact device.The relevant design drawings were reviewed.Review of the device history record showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.The complaint condition is confirmed for a bent device as the screwdriver (part # 357.417, lot # 7789051) was received with the flexible shaft bent in a couple places.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.
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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.
Event or Problem Description
This report is for a 5.0mm flexible hexagonal screwdriver coated.

• 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: 7841944
• Report Number: 2939274-2018-53578
• Device Sequence Number: 1338693
• Product Code: HXX
• UDI-Device Identifier: 10886982196293
• UDI-Public: (01)10886982196293
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2018

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: 7789051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 10/09/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/27/2018; 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1