MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK; REAMER

Model Number 351.16J

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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.

Event Description

It was reported that during a routine inspection on (b)(6) 2020, several issues were noted.The multi hole wire guide tip has been damaged; guide wires cannot go through.The ratcheting screwdriver handle is chipped.The flexible shaft connector for use with jacobs chuck is missing the internal part that locks in shaft.And the handle with quick coupling is broken at the top of the handle.There was no patient involvement.This report is for a flexible shaft connector for use with jacobs chuck.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: d11: concomitant devices reported.-provisional tensioning device, -handle with quick coupling, -flexible shaft connector for use with jacobs chuck.-depth gauge for 2.0mm and 2.4mm screws.-universal chuck with t-handle.-ratcheting screwdriver handle.-multi hole wire guide.H3, h4, h6: device history lot part # 351.16j.Lot # l302143.Manufacturing site: bettlach.Release to warehouse date: 14.Feb.2017.H6: investigation summary: service and repair evaluation: the customer reported that the flexible shaft connector for use with jacobs chuck missing internal part that locks in shaft.The repair technician reported that there is a pin missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: chuck pin.The item was repaired per the inspection sheet, passed synthes final inspection on 05-jan-2021 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.A manufacturing record evaluation was performed for the finished device lot number, 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.

• Brand Name: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11155051
• MDR Text Key: 226577651
• Report Number: 2939274-2021-00188
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982193742
• UDI-Public: (01)10886982193742
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 351.16J
• Device Catalogue Number: 351.16J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK; HANDLE WITH QUICK COUPLING; MULTI HOLE WIRE GUIDE; PROVISIONAL TENSIONING DEVICE; RATCHETING SCREWDRIVER HANDLE; UNIVERSAL CHUCK WITH T-HANDLE