MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING; TAP, BONE

Catalog Number	311.01.96
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Initial reporter is a synthes sales representative.A service and repair evaluation was completed: the repair technician reported the device handle is broken.Handle cracked/broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the handle was broken; broken fragment was returned.The lot number etched on the device is unreadable as there were nicks on the handle.No other issues were identified with the returned device.No dimensional inspection can be performed due to post-manufacturing damage.The current revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 or Problem Description
It was reported that on an unknown date, upon resetting and prepping a tray for surgery, the phenolic resin handle with mini quick coupling of the screwdriver was cracked in three (3) places and almost ready to fall apart.It can no longer be used in surgery safely.This incident did not affect the patient.There is no patient consequence.During the investigation it was noted, the handle was broken.This report is for a handle with mini quick coupling.This is report 1 of 1 for (b)(4).

• Brand Name: HANDLE WITH MINI QUICK COUPLING
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11109920
• Report Number: 2939274-2021-00014
• Device Sequence Number: 14377340
• Product Code: HWX
• UDI-Device Identifier: 10886982187208
• UDI-Public: (01)10886982187208
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 311.01.96
• Device Lot Number: A4HL921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1