MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM THREADED SPINDLE 330MM; TRACTION,APPARATUS,NON-POWERED

Model Number	394.41
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is a j&j representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, the universal chuck, screwdriver shaft, hammer guide, stardrive screwdriver shaft, cannulated hexagonal screwdriver, threaded rod and universal chuck with t-handle are found broken during the inspection outside the surgery.Patient involvement is unknown.This complaint involves (7) devices.This report is for (1) 14.0mm threaded spindle 330mm.This report is 7 of 8 for (b)(4).
Additional Manufacturer Narrative
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.H3, h4, h6: lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.Update by (b)(4) on 28.09.2021.The lot# 4l88723 belongs to subcomponent# 3340 part: 3340.Lot: 4l88723.Manufacturing site: bettlach.Release to warehouse date: 30 october 2019.A manufacturing record evaluation was performed for the finished device part: 3340, lot: 4l88723 , and no non-conformances related to malfunction were identified.Visual inspection: the 14.0mm threaded spindle 330mm (p/n 394.41, lot #: 4l88723) was received at us customer quality (cq).Visual inspection showed the external threads were stripped.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection could not be conducted due to post-manufacturing damage.Document/specification review: the following drawing, reflecting the manufactured and current revision, were reviewed.Complaint confirmed? yes.Conclusion: the complaint condition is confirmed as the device was stripped.However, no broken features were observed.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: 14.0MM THREADED SPINDLE 330MM
• Common Device Name: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12392787
• Report Number: 2939274-2021-05054
• Device Sequence Number: 11856590
• Product Code: HST
• UDI-Device Identifier: 10886982199690
• UDI-Public: (01)10886982199690
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Model Number: 394.41
• Device Catalogue Number: 394.41
• Device Lot Number: 4L88723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; HAMMER GUIDE FOR SLIDE HAMMER; NUT-KNURLED F/LARGE-DISTRACT; SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC; SDDRIVE SCREWDRIVER SHAFT T8 105MM; UNIVERSAL CHUCK; UNIVERSAL CHUCK WITH T-HANDLE; CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; HAMMER GUIDE FOR SLIDE HAMMER; NUT-KNURLED F/LARGE-DISTRACT; SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC; SDDRIVE SCREWDRIVER SHAFT T8 105MM; UNIVERSAL CHUCK; UNIVERSAL CHUCK WITH T-HANDLE