MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.085
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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
It was reported that on an unknown date, during a routine incoming inspection of loaner set it was observed that helical blade/screw extractor was returned with trochanteric fixation nail advance (tnfa) screw stuck to the removal device.There was no patient involvement.This report is for one (1) tfna screw 85mm.This is report 2 of 2 for complaint (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.Investigation summary the tfna screw 85mm (p/n 04.038.085 lot unk) was received stuck at the distal coupling tip of the helical blade/screw extractor.Additionally, deep scratches were observed along the implant, resulting in the lot number to be illegible.No other issues were identified with the returned components of the device.Functional testing showed that the tfna screw could not be removed from the helical blade/screw extractor.The two parts are stuck/jammed.The reported complaint condition could be replicated as the tfna screw was stuck to the helical blade/screw extractor and could not be disassembled.Dimensional inspection of the cannulation of the coupling feature could not be conducted as the devices could not be disassembled for inspection.Drawings, reflecting the current revision, was reviewed since the lot and manufacture date is unknown, and a manufacture/document review evaluation was unable to be performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed for the tfna screw 85mm (p/n 04.038.085 lot unk) as the implant was stuck at the distal coupling tip of the helical blade/screw extractor.Additionally, deep scratches were observed along the implant, resulting in the lot number to be illegible.While no definitive root cause could be determined, it is possible that excessive force was used to mate the two devices.This possibility is further supported with deep scratches observed on the helical blade.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part number: 04.038.085, lot number: 9919, part manufacture date: n/a, manufacturing location: n/a, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira.The part was received and deep scratches were observed along the implant, resulting in the full lot number to be illegible.Only the first 4 digits (9919) is legible.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: TFNA SCREW 85MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8719044
• Report Number: 2939274-2019-58792
• Device Sequence Number: 2073004
• Product Code: HSB
• UDI-Device Identifier: 10886982098443
• UDI-Public: (01)10886982098443
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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 Model Number: 04.038.085
• Device Catalogue Number: 04.038.085
• Device Lot Number: 9919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1