MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE/SCREW GUIDE SLEEVE; SURGICAL DRILL GUIDE, REUSABLE

Model Number 03.037.017

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

This is report 4 of 5 for (b)(4).It was reported by the sales rep that during an unknown procedure on (b)(6) 2022, the triple assembly sleeve for blade/screw in the tfna set was inserted into the 130* aiming arm when resistance was felt trying to slide the triple sleeve into the aiming arm.According to the report, the triple sleeve was able to be fully inserted but once insertion of the helical blade was done and disconnected from the inserter, it was reported that the surgeon could not remove triple sleeve assembly out of the 130* aiming arm.It was reported that the triple assembly sleeve was stuck in the aiming arm and could not be removed until after the procedure was finished.It was reported that the threads on the compression nut and blade/screw guide sleeve appeared to be stripped.The procedure was completed successfully with a delay of 15 minutes.There were no adverse patient consequences reported.No additional information was provided.This complaint involves five (5) devices.

Manufacturer Narrative

Additional narrative: 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.Reporter is a j&j sales representative.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the blade/screw guide sleeve was found to have nicks along the threads and several sections are stripped.A dimensional inspection for the blade/screw guide sleeve was unable to be performed due to post manufacturing damage.A functional test was performed, the blade/screw guide sleeve was inserted into the guidance attachment hole, it was possible to advance up to the middle section of the shaft, assembling issues are most likely due to the stripped condition of the guide sleeve threads.Additionally, the guide sleeve was inserted into the compression nut hole, nut would not rotate smoothly, this condition is most likely due to the stripped condition of the sleeve and stripped condition of the nut.The complaint condition was able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the blade/screw guide sleeve would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: yes, no issues.Dimensional inspection: n/a.Device history part #: 03.037.017-us.Lot #: 9409791.Manufacturing site: werk bettlach.Supplier: n/a.Release to warehouse date: 12 mar 2015.Expiration date: n/a.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: BLADE/SCREW GUIDE SLEEVE
• Type of Device: SURGICAL DRILL GUIDE, REUSABLE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14488667
• MDR Text Key: 292975059
• Report Number: 2939274-2022-01907
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982070333
• UDI-Public: 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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: 9409791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1