MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLD GUIDE SLEEVE FOR TFN; APPARATUS, TRACTION, NON-POWERED

Model Number 357.369

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6), 2022, during a procedure the surgeon inserted the blade/sleeve into the aiming arm and pushed in the buttress/compr-nut f/357.369 and guide sleeve f/helical blade f/tfn in to the aim-arm f/tfn 130°, which popped out of the aiming arm three(3) times.Another set was opened up and the case was finished with no issues.Procedure was completed successfully with a surgical delay of three(3) minutes.No patient consequences.This report is for one (1) bld guide sleeve for tfn.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

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, h6: a product investigation was conducted.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 guide sleeve f/helical blade f/tfn (p/n: 357.369, lot: 4571090) had normal cosmetic details as wear and scratches in the surface, that could be caused for repetitive use or unintended forces applied.However, no malfunctions or defects were identified that could be attributable to the reported allegation.A functional test was performed to the involved products aim-arm f/tfn 130° (p/n: 357.366), buttress/compression nut (p/n: 357.371) and guide sleeve f/helical blade f/tfn (p/n: 357.369).During the functional test, the guide sleeve f/helical blade f/tfn was assembled with the mating devices with no issues identified.Also, the involved pieces were disassembled with no problems.A dimensional inspection was performed for the guide sleeve f/helical blade f/tfn (p/n: 357.369, lot: 4571090) and met specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the guide sleeve f/helical blade f/tfn (p/n: 357.369, lot: 4571090).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.H3, h4, h6: a device history record (dhr) review was conducted: part #: 357.369.Synthes lot number: 4571090.Manufacturing site: synthes brandywine.Release to warehouse date: (b)(6) 2004.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: BLD GUIDE SLEEVE FOR TFN
• Type of Device: APPARATUS, TRACTION, 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13621280
• MDR Text Key: 286884157
• Report Number: 2939274-2022-00706
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196033
• UDI-Public: (01)10886982196033
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357.369
• Device Catalogue Number: 357.369
• Device Lot Number: 4571090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2004
• 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
• Treatment: 130 DEG AIM ARM F/TFN; BUTTRESS/COMPRESSION NUT FOR 357.369
• Patient Age: 95 YR
• Patient Sex: Female