MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE/SCREW GUIDE SLEEVE

Model Number 03.037.017

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j sales representative.Investigation summary: device interaction/functional.Visual inspection: the blade/screw guide sleeve (part #: 03.037.017, lot #: l274029) was received at us cq.Upon visual inspection of the device and the photo located in notes and attachment section under file "17072417-262a-44c0-b83e-87e29e3f21e6.Jpeg", it was observe that two of the external threads of the device were warped.The buttress compression nut was also found stuck in the threaded portion of the device.Scratches were also observed on the device.Functional test: during functional assessment, the stuck buttress compression nut was able to rotate in clockwise and counter-clockwise directions but could not pass the damaged thread on the device due to the damaged thread.So the buttress compression nut was stuck.The complaint can be replicated with the returned device.Dimensional inspection: no dimensional inspection was performed due to the complaint condition.Document/specification review: no design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint is confirmed as the blade/screw guide sleeve (part #: 03.037.017, lot #: l274029) was found to be have two of its external threads damaged.A mating device was also found to be stuck in the thread area.The reported condition could not be confirmed based on the result of the visual inspection performed.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 03.037.017-us, lot: l274029, manufacturing site: (b)(4), release to warehouse date: march 28, 2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 unknown threaded trocar threads was damaged.Procedure was delayed for four(4) minutes.This complaint involves three (3) devices.This report is for one (1) blade/screw guide sleeve.This is report 3 of 3 for complaint (b)(4).

• Brand Name: BLADE/SCREW GUIDE SLEEVE
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12453863
• MDR Text Key: 271095729
• Report Number: 2939274-2021-05307
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982070333
• UDI-Public: (01)10886982070333
• 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: 08/30/2021

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 Model Number: 03.037.017
• Device Catalogue Number: 03.037.017
• Device Lot Number: L274029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/10/2021
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1