MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT 620MM; REAMER

Model Number 352.044

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Part: 352.044-us, lot: l710625, manufacturing site: (b)(4), release to warehouse date: 10 january 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the 5.0mm flexible shaft 620mmt (p/n 352.044, lot # l710625) was received at us customer quality (cq).Upon visual inspection of the returned device and the images, it was observe that the prongs on the distal end of the device were bent/deformed.Unknown foreign material, which could be blood was observed on the outer surface of the prongs on the device.Additionally scratches from field usage were observed on the device.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: complaint relevant dimensional analysis cannot be performed due to the geometry/design of the device.Document/specification review: based on the manufactured date of the device, the current and manufactured revision of drawings were reviewed: flex.Welle no design issues or discrepancies were identified.Complaint confirmed? yes, the device received was deformed/bent.Hence confirming the allegation.Conclusion: the complaint was confirmed as the proximal end of the device was bent/deformed.The unintended external forces might have contributed to the reported complaint condition.There was no indication that a design or manufacturing issue has caused the deformed/bent 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.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 an unknown date the end of item bent and the wire would not slide through well.This report is for one (1) 5.0mm flexible shaft 620mm.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT 620MM
• Type of Device: REAMER
• 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: 12449038
• MDR Text Key: 270781813
• Report Number: 2939274-2021-05266
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194138
• UDI-Public: 10886982194138
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.044
• Device Catalogue Number: 352.044
• Device Lot Number: L710625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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