MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 14MM; SCREW, FIXATION, BONE

Model Number	02.210.114
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hrs.Device malfunctioned intra-operatively and was 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
It was reported that during a distal radius procedure on an unknown date, when the surgeon inserted a locking screw using a 1.8 threaded drill guide in the proximal portion in the shaft of a 2.4mm variable angle locking compression plate (va ¿ lcp) two column volar distal radius plate, the screw would not lock into the plate.Instead, they used a 2.4 cortical screw.There was no other medical intervention required.There was no patient consequence reported.There was a 5-minutes delay during the procedure.The procedure was successfully completed.Concomitant device(s): 1.8 threaded drill guide (part#: unknown; lot#: unknown; quantity: 1) this report is for a 2.4mm va locking screw stardrive 14mm this is report 1 of 2 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.Subject device has been received and is currently in the evaluation process.Corrected data: date of event.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.Product development investigation was completed.The returned screw (02.210.114) is used in variable angle locking intercarpal fusion system.The technique guide states to perform screw engagement and final locking only manually using the torque limiting attachment and the handle.Visual inspection under 10x magnification performed at customer quality observed that the threaded portion on the head of the screw was slightly worn.No issues were observed on the remaining portions of the returned screw.The complaint condition agree with the complaint description and the complaint condition was confirmed.Functional test was unable to be performed as the mating device(plate) was not returned.Therefore, complaint condition was not able to be replicated at the customer quality.Relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.Feature specifications per drawing: head thread major diameter ø3.35 +/-0.3mm and tolerance measured (ca-814): ø 3.40 mm.The measured dimensions were found to be within the given specifications.While no root cause could be determined it is likely that any unintended off-axis alignment of screw during the procedure could have contributed to worn threads at the screw head which in turn could have contributed to the complaint condition.Also, the technique guide suggests removing guide for final tightening of the screw.Therefore, it is possible that any unintended failure to follow the warning and cautions suggested in technique guide during screw engagement could have also contributed to the complaint condition.During the investigation, no product design or manufacturing issues or discrepancies 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: 2.4MM VA LOCKING SCREW STARDRIVE 14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7526561
• Report Number: 2939274-2018-52225
• Device Sequence Number: 1169575
• Product Code: HWC
• UDI-Device Identifier: 10886982052919
• UDI-Public: (01)10886982052919
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• 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): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.210.114
• Device Catalogue Number: 02.210.114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 06/26/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/14/2018; 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention