MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED

Catalog Number 357.371

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales consultant.Device history lot part number: 357.371, synthes lot number: 7638321, supplier lot number: 7638321, release to warehouse date: 11-jun-2014, manufacturing site: synthes monument.Supplier: (b)(4).No ncrs were generated during production.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.Investigation summary: the buttress/compression nut does thread properly on a blade guide sleeve thread, it gets stuck at the top of the guide sleeve.There was no patient involvement.Visual inspection: the buttress/ compression nut for 357.369 (part # 357.371, lot # 7638321, mfg # 11-jun-2014) was received with the buttress/compression nut stuck at the top of the blade guide sleeve.The buttress nut shows signs of minimal wear.Functional test: the buttress/compression nut is stuck at the top of the blade guide sleeve and the two parts are unable to be separated.The complaint was not able to be replicated since the buttress nut cannot be unscrewed from the blade sleeve and screwed on again.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not able to be performed since the buttress nut is stuck and unable to be separated.Therefore, no relevant dimensions could be measured.Conclusion: the complaint condition is confirmed as the buttress nut (part # 357.371, lot # 7638321) was received stuck at the top of the blade guide sleeve.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.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) 2018, helical blade inserter top screw (connecting screw) is not functioning properly, it won't screw in and lock the gold handle in places.In addition, the buttress/compression nut does thread properly on a blade guide sleeve thread, it gets stuck at the top of the guide sleeve.There was not patient involvement.This report is for one (1) buttress/compression nut for 357.369.This is report 4 of 4 for (b)(4).

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8206147
• MDR Text Key: 131715759
• Report Number: 2939274-2018-55642
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196057
• UDI-Public: (01)10886982196057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Device Lot Number: 7638321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1