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

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown locking screw.A partial part number was identified as 212.8xx.Information pertaining to this part family is as follows: 2.4mm locking screw slf-tpng with stardrive recess 10mm.Additional product codes, based upon the partial part family, for this report include hrs.The complainant part is not expected to be returned for manufacturer review/investigation.Based upon the partial part number provided, the likely 510k number for the device is k102694.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 a patient was implanted with a temporary wrist spanning internal fixation construct on an unknown date due to a wrist fracture.The construct consisted of a 2.4mm locking compression (lcp) straight wrist plate and six (6) locking screws.Part of the treatment plan was to remove the hardware on (b)(6) 2015.The patient underwent the hardware removal as scheduled.During the removal process, the surgeon experienced difficulty explanting one (1) of the 2.4mm locking screws from the plate.The surgeon attempted to pry and pull the plate.Upon removal, it was noted that the screw, in its entirety, remained stuck in the plate's screw hole.A surgical delay of an unknown length was noted.The remaining five (5) screws were removed without difficulty.The procedure was completed without further incident.This report is for one (1) unknown locking screw.This report is 2 of 2 for (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5326792
• MDR Text Key: 34333307
• Report Number: 2520274-2015-18102
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1