MAUDE Adverse Event Report: SYNTHES (USA) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; PLATE, FIXATION, BONE

Catalog Number 02.211.018

Device Problems Break (1069); Material Fragmentation (1261); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Additional device product code is hwc.(b)(4).Due to the intra-operative events, the device was not successfully implanted.As such, no implant/explant dates are applicable.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the reporting facility.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 procedure on (b)(6) 2016, a 2.7 (variable angle) va 18mm locking screw stripped while inserting it into a 3.5mm (locking compression plate) lcp superior clavicle plate.The tip of the stardrive screwdriver shaft t8 105mm used for inserting the screw became twisted.The screw was inserted under power without a torque limiting attachment.While trying to remove the screw, it broke.The head of the screw remained in the locking hole of the plate and was retained in the patient.The shaft of the broken screw was removed using with pliers.This resulted in a fifteen minute surgical delay.The plate remained implanted.There was no patient harm and the remainder of the procedure was completed successfully.The patient outcome was satisfactory.This report is 2 of 2 (b)(4).

Manufacturer Narrative

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

Concomitant devices reported: 3.5mm lcp superior clavicle plate w//lat extn/6h/lt/105mm (part 02.112.091, lot unknown, quantity 1).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5802341
• MDR Text Key: 49812938
• Report Number: 2520274-2016-13508
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103243
• 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,Followup
• Report Date: 07/01/2016

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
• Device Catalogue Number: 02.211.018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR