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

Catalog Number	357.406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id reported as (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A device history record review has been requested.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, a flexible hexagonal screwdriver broke during a left trochanteric fixation nail (tfn) surgery.No fragments were generated.A backup device was available.Procedure was successfully completed with no surgical delay.There was no patient impact.This report is for a 5.0mm flexible hexagonal screwdriver.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device history records review was completed for part: 357.406, lot: 4938633, supplier lot: 2239950001.Supplier: precimed, release to warehouse date: feb 03, 2005.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Product investigation was completed.When viewing the device with the part number on the handle facing upwards the distal portion on the left side shows a portion of the handle broken off and the fragment was not returned.Additionally, there is a significant bend on the flexible shaft portion of the device towards the distal tip.There are no visual signs of anything broken with the shaft.The balance of the device shows surface wear consistent with use and which would not impact the functionality.The received condition does agree with the complaint description for broken and is confirmed.The cause of the issue could not be determined to be use error, misuse/abuse, noncompliance, postoperative trauma.Dimensional inspection was performed and conform to specification.No design or manufacturing defect or deficiency was observed during the investigation.A device history review, was performed for the returned instrument¿s lot number, and no non conformation reports, no material record reviews or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.However, the received condition is consisted with the device encountered unintended forces.During the investigation, no product design or manufacturing issues were observed that 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
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8236579
• Report Number: 2939274-2019-55772
• Device Sequence Number: 11198820
• Product Code: HXX
• UDI-Device Identifier: 10886982196293
• UDI-Public: (01)10886982196293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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: 357.406
• Device Lot Number: 4938633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 115