MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 3.5MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Catalog Number	314.19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 during a procedure on (b)(6) 2018, to loosen a distal radius external fixation device, the tip of a 3.5mm cannulated screwdriver broke off.All fragments were retrieved.There was another instrument immediately available and the procedure was completed successfully.Patient outcome was satisfactory.Concomitant devices reported: unknown distal radius external fixation (part #: unknown, lot #: unknown, qty.Unknown).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
The device was received and the product evaluation is in progress.No conclusion can be drawn.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.H3, h4, h6: a device history record review was performed for the subject device: part: 314.190.Lot: 1939879.Manufacturing site: haegendorf.Release to warehouse date: 10.July 2008.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that 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.H3, h6: a product development investigation was performed for the subject device: it was reported that during a procedure to loosen a distal radius external fixation device, the tip of a 3.5mm cannulated screwdriver broke off.There was another instrument immediately available and the procedure was completed successfully.Patient outcome was satisfactory.The following investigation flow was performed: broken.Visual inspection performed at customer quality (cq) confirmed the condition of breakage, which agrees with the reported complaint condition.The distal cannulated hexagonal tip has broken off.The transverse break occurred mid hex feature.The broken off tip fragment was also returned.The returned device was manufactured in july 2008 and is over 9 years old.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that 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.Cannulated hexagonal screwdriver assembly drawing 314_19 revisions n-r and screwdriver shaft component drawing 314_19_1 revisions h&j were reviewed during this investigation.No product design issues or discrepancies were observed.The cannulation/inside diameter at location of breakage measured ø2.14mm at cq (gp29) which is within specification of ø2.1mm +0.2mm per screwdriver shaft component drawing 314_19_1.The distal hex flat to flat width at location of breakage measured 3.50mm at cq (ca592) which is within specification of 3.5mm -0.02mm per screwdriver shaft component drawing 314_19_1.The distal hex point to point width at location of breakage measured 3.89mm at cq (ca592) which is within specification of 3.95mm -0.1mm per screwdriver shaft component drawing 314_19_1.This complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this investigation.A definitive root cause was not able to be determined.It is most likely that the force required to loosen the external fixation device exceeded the strength of the returned cannulated hexagonal screwdriver.Strengthwise, a solid (non-cannulated) screwdriver is the preferred instrument for attempted removal of screws, provided a guided trajectory over a guidewire is not required.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: CANNULATED 3.5MM 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: 7437041
• Report Number: 2939274-2018-51773
• Device Sequence Number: 1146516
• Product Code: HXX
• UDI-Device Identifier: 10886982188663
• UDI-Public: (01)10886982188663
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/29/2018

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: 314.19
• Device Lot Number: 1939879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 06/07/2018; 06/21/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/11/2018; 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR