MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 03.037.013

Device Problem Material Deformation (2976)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2021 during a tfna procedure, the guide wire aiming device was unable to thread into the 130 degree aiming arm.The threads inside the aiming arm may be stripped or bent.This was discovered during a case, but did not effect the surgery.There was no patient involvement.This report is for one (1) 130 deg aiming arm.This is report 1 of 1 for (b)(4).

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.Visual inspection: the complaint device aiming arm (product code: 03.037.013, lot number: 18p9804) was returned to cq west chester for investigation.The aiming arm had scratch marks consistent with use and the lock/latch appeared to be loose.No other issues were identified.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Aiming arm tfna 130° se_434587 rev i (current) and rev h (manufactured).Dimensional inspection: complaint relevant dimension could not be measured due to the design of the device.Complaint confirmed: complaint condition of deformed/bent cannot be confirmed based on the available information.Conclusion: the aiming arm had scratches and loose latch, hence the overall complaint is being confirmed.A definitive root cause was not determined during investigation.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 preventative 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: 03.037.013-us, lot: 18p9804, manufacturing site: hägendorf, release to warehouse date: 07 november 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.Planned non-product non conformity aims to monitor and control specific activities to manage all work orders (wo) and purchase orders (po) which are in wip during the cutover phase from old erp to new erp.Products are not impacted.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: 130 DEG AIMING ARM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12731292
• MDR Text Key: 279906323
• Report Number: 2939274-2021-06425
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642393
• UDI-Public: (01)07611819642393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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 Catalogue Number: 03.037.013
• Device Lot Number: 18P9804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES