MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.037.016

Device Problems Use of Device Problem (1670); Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 Description

It was reported that on (b)(6) 2019, during an unknown procedure, the trochanteric fixation nail advance (tfna) blade/screw guide sleeve and buttress/compression nut were stripped.There was a surgical delay of five to ten (5-10) minutes as the knot would not advance onto the threaded sleeve.Patient status is unknown.This complaint involves 2 devices.This report is for 1 buttress/compression nut.This report is 2 of 2 for (b)(4).

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: device history part: 03.037.016, lot: 9423672, manufacturing site: haegendorf, release to warehouse date: 06.May 2015.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.H3, h6: investigation summary: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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: BUTTRESS/COMPRESSION NUT
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8317622
• MDR Text Key: 135516178
• Report Number: 2939274-2019-56350
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982070326
• UDI-Public: (01)10886982070326
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.016
• Device Lot Number: 9423672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/08/2019
• Patient Sequence Number: 1