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

Catalog Number 03.037.016

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 the buttress compression nut and blade/screw sleeve are found stuck together.Issue was discovered in sterile processing when attempting to get the pieces apart.Physical damage was visible on the devices, possibly from attempts to get the devices apart.No patient involvement was reported.Concomitant devices reported: aiming arm locking device (03.037.015, lot number unknown, quantity 1), 130 degree aiming arm (03.037.013, lot 9282814, quantity 1).This report is for one (1) buttress/compression nut.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record (dhr) review was conducted for part: 03.037.016, lot: 9423627: manufacturing site: (b)(4), release to warehouse date: 27.Apr.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.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.The instrument was received with the reported condition of ¿device interaction (2+ devices) unable to disassemble: rm¿ visual inspection using 10x magnification performed at customer quality observed that the buttress/compression nut has slightly nicked threads all over its length.The nut is stuck on the most proximal thread region of the guide sleeve.A functional test was conducted, and the buttress nut could not be moved/translated on the guide sleeve (03.037.017) at cq.The received condition does agree with the complaint description.The complaint condition could be replicated.The relevant feature is unable to be accessed as the device cannot be separated from the mating devices, therefore a dimensional inspection is unable to be completed.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing and no issues were detected.While no definitive root cause could be determined, it is likely that any unintended off-axis alignment during its use could have contributed to nicked surfaces of the device which in turn contributed to stuck complaint condition.During the investigation, no product design or manufacturing issues 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: BUTTRESS/COMPRESSION NUT
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7639236
• MDR Text Key: 112572007
• Report Number: 2939274-2018-52637
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.016
• Device Lot Number: 9423627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1