MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.033.006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 incoming inspection of a loaner set at (b)(4) site on an unknown date, cannulated connecting screw was observed to be broken.There were no patient and surgical involvement reported.This complaint involves one (1) device.This report is for one (1).This is report 1 of 1 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the cannulated connecting screw (p/n: 03.033.006, lot #: l8963246) was received at us cq.Upon visual inspection, the complaint device has a black foreign substance inside the hex head and partially down inside the shaft.No device damage was observed.The overall complaint was not confirmed for the received cannulated connecting screw (p/n: 03.033.006, lot #: l8963246) as the device is not damaged but has foreign substance inside of the device.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 history lot: part: 03.033.006.Lot: l863246.Manufacturing site: hägendorf.Release to warehouse date: 08.June 2018.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: CANNULATED CONNECTING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9496938
• MDR Text Key: 193625735
• Report Number: 2939274-2019-62722
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.033.006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1