MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN

Catalog Number	03.010.415
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number 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.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.(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.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent an unknown procedure.During the procedure, the guide wire aiming device for the trochanteric fixation nail (tfn) and two (2) connecting screws for guide wire aiming device were not interfacing correctly with 125 degree and 130 degree aiming arms.The tools were abandoned from usage.Visual technique was used to proceed with nail depth assessment.A user error was suspected and follow-up equipment inspection was needed.The connecting screws were found bent and the threads were damaged.The procedure was successfully completed with 2 minutes of surgical delay due to swapping of the second connecting screw.The patient was reportedly fine at the end of the procedure.In addition, on june 11, 2018, a non-sterile inspection was done which validated the confirmation of a poor interface.Concomitant device/s reported: 125 degree aiming arm (part: 03.037.014, lot: unknown, quantity: 1); 130 degree aiming arm (part: 03.037.013, lot: unknown, quantity: 1).This report is for a connecting screw f/guide wire aiming device f/tfn.This is report 3 of 3 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.Part: 03.010.415; synthes lot: 8974016; manufacturing date/release to warehouse date: august 08, 2014; manufacturing site: hägendorf.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The following investigations were performed: device interaction/functional: device condition: visual inspection performed at customer quality observed the returned connecting screw to be slightly bent at is transition from shaft to threaded portion.No new issues were identified other than over all worn surfaces on the returned devices which will not affect the device functionality.The device was functionally tested with the returned aiming arm guide and no issues such as stuck conditions were observed.However, functional inspection on the construct including the aiming arm and replication of complaint condition was not able to be performed as the mating device (aiming arm) was not received.However, with the damage identified, the complaint condition agree with the complaint description and the complaint condition was confirmed.Drawing review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.Top level drawing threaded shaft drawing dimensional analysis and document/specification review: dimensional inspection performed at the shaft measured the diameter as 3mm (ca-814) which falls within the specifications of 3mm +/- 0.1mm and tolerance specified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Conclusion: a definitive root cause could not be determined from the provided information.However, it is likely that any unintended off-axis alignment of devices during usage could have contributed to this complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during 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.H10 additional narrative: h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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: CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7658093
• Report Number: 2939274-2018-52694
• Device Sequence Number: 11265608
• Product Code: FZX
• UDI-Device Identifier: 10886982068590
• UDI-Public: (01)10886982068590
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2018

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: 03.010.415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/02/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/27/2018; 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018; THERAPY DATE: (B)(6) 2018