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

Model Number 352.040

Device Problem Device Damaged Prior to Use (2284)

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

Event Type  malfunction  

Manufacturer Narrative

The 5.0mm flexible shaft (p/n: 352.040, lot number: 65p7298) was received at us cq.Visual inspection of the complaint device showed the distal tip prongs had bent.No packaging was received to confirm the defect happened upon arrival of the device.Device failure/defect identified? yes.A dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no.This complaint is not confirmed as no packaging was received to confirm the defect happened upon arrival of the device.However, the distal tip prongs had bent.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 # 352.040-us.Lot # 65p7298.Manufacturing site: (b)(4).Release to warehouse date: 07 september 2020.A manufacturing record evaluation was performed for the finished device 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the 5.0mm flexible shaft was defective prior to use.There was no patient consequence.There is no further information available.This report is for one (1) 5.0mm flexible shaft.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT
• 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 GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11868817
• MDR Text Key: 252274870
• Report Number: 2939274-2021-02516
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: 10886982194114
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.040
• Device Catalogue Number: 352.040
• Device Lot Number: 65P7298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• 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