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

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Event date: unknown date in 2018.This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent an unknown procedure.The screw issue on a variable angle locking compression olecranon plate was where the screw ran from proximal plate end towards ulna diaphysis.Upon screw insertion, the unknown locking screw distal thread was detaching from the screw shaft and the screw was no longer considered as locked screw.The surgeon wanted to put a locking screw through most of the proximal hole in order to reach the diaphysis rather than the throchlea.They needed to angulate the screw more than the allowable fifteen (15) degrees.The surgeon insisted on inserting the screw in that condition which then caused all of the screw thread to peel off.The surgeon then decided to use an unknown plate and screw construct (accumed) in order to complete the procedure.It is unknown if there was surgical delay.Patient and procedure outcome are unknown.Concomitant device reported: variable angle locking compression olecranon plate (part# 02.107.202, lot# unknown, quantity#) this report is for one (1) unknown- screws: locking 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.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

Synthes devices were implanted successfully and no non-synthes devices were used.

• 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: 8186362
• MDR Text Key: 131189389
• Report Number: 2939274-2018-55509
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention