MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.It is unknown if the screw was implanted or not.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the patient underwent open reduction internal fixation of olecranon and radial head, and olecranon plate implantation on (b)(6) 2018.The 4 hole 2.7/3.5 va olecranon plate was implanted and the two locking screws holes were left empty.During the procedure two of the locking holes in the plate did not allow the (2) unknown locking screws to engage and would not lockdown into the plate, and with pressure used to try and insert the screw, the holes began to strip the threads of the screw.It was noted that unknown cortex screw and unknown locking screw were used to attached the plate.There was a five (5) minute surgical delay reported.The procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: cortex screw (part 202.Xxx, lot unknown, quantity unknown); locking screw (part 02.211.Xxx, lot unknown, quantity unknown) this report is for an unknown screw.This is report 3 of 3 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.The initial complaint was reviewed and found not reportable.This ip will be voided as only the locking screw malfunctioned and there is no allegation against this unknown screw.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

The initial complaint was reviewed and found not reportable.This ip will be voided as only the locking screw malfunctioned and there is no allegation against this unknown screw.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7603193
• MDR Text Key: 111158623
• Report Number: 2939274-2018-52509
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1