MAUDE Adverse Event Report: SYNTHES USA; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Date of event: unknown.This report is for unknown screw locking, 2.7 mm variable angle/unknown lot number.Other udi: (01) unknown (10) lot number unknown.Udi unavailable.This plate and screw construct was initially implanted on an unknown date.Device is not expected to be returned for manufacturer review/investigation.Pma/510k#: unknown.The complaint indicated that the screw backed out/pulled out post-op requiring additional surgical intervention.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, 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.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 a patient underwent a removal of a 2.7 mm variable angle (va) locking screw on (b)(6) 2017 that had backed out of a plate in the distal humerus.This plate and screw construct was initially implanted on an unknown date.The original plan was to revise the patient to a new 2.7 mm va locking screw.After removing the backed out screw, when the surgeon tried to revise the patient to the new locking screw, it wouldn't lock.Hence, the new locking screw was also removed and the patient was left with plate and unknown number of screws present from the initial implant conducted about three weeks before the removal surgery.There were no other complications during the removal surgery.No surgical delay was reported.The patient's condition is reported to be stable.This complaint involves one (1) device.Concomitant devices reported: unknown plate (part # unknown, lot # unknown, quantity # unknown).This report is 1 of 1 for (b)(4).

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7043139
• MDR Text Key: 92463800
• Report Number: 2520274-2017-12669
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR