MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HEX ADAPTOR-QC HIGH-STRENGTH; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 03.617.941

Device Problem Compatibility Problem (2960)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Product code 03.617.941, lot#: l999889, manufacturing site: haegendorf.Release to warehouse date: 10.Dec.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the hex adaptor-qc high-strength (p/n: 03.617.941, lot number: l999889) was received at us customer quality (cq).Visual inspection of the complaint device showed the shaft was bent.A functional assessment was performed on the complaint device with the returned mating device.The devices were able to easily assemble and disassemble without any issues.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured was reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.This complaint is not confirmed as the device is able to assemble and disassemble smoothly with the mating device.However, the shaft was 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 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 an anterior cervical discectomy and fusion (acdf) while tightening a cervical spine screw with the angled screwdriver (shaft for angled screwdriver and hex adaptor), the instrument didn¿t work correctly.The surgery was completed without any delay or issues with a straight screwdriver from our set.Upon inspecting the part after surgery it was discovered that at least one component (hex adaptor) was bent.Cervical spine screw (part# 04.647.836; lot# unknown; quantity 1).Inner shaft for angled screwdriver (part# 03.617.905; lot# unknown; quantity: 1).This report is for one (1) hex adaptor-qc high-strength.This is report 1 of 1 for (b)(4).

• Brand Name: HEX ADAPTOR-QC HIGH-STRENGTH
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 11545965
• MDR Text Key: 244878637
• Report Number: 2939274-2021-01477
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10705034717272
• UDI-Public: 10705034717272
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.617.941
• Device Catalogue Number: 03.617.941
• Device Lot Number: L999889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 89