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	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter is synthes sales representative.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 on an unknown date during an unknown surgery, a flexible hexagonal screwdriver broke.It was unknown if there was a surgical delay.Patient and surgical outcome were unknown.This report is for one (1) 5.0mm flexible hexagonal screwdriver coated.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.The initial complaint was reviewed and found not reportable.This complaint is confirmed to be a duplicate of (b)(4).This incident will be reported under (b)(4).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.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
Further it was reported that on (b)(6) 2018, a flexible hexagonal screwdriver was broken during a nail removal procedure.Other items were being used but there were no issues with those.

• 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: 7842578
• Report Number: 2939274-2018-53596
• Device Sequence Number: 1271652
• Product Code: HXX
• UDI-Device Identifier: 10886982196408
• UDI-Public: (01)10886982196408
• 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): 08/17/2018

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: 357.417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 10/12/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1