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 Problem Difficult to Insert (1316)

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

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient weight is unknown.Additional product codes for this report include hwc.(b)(4).Due to the intraoperative event, the device was not implanted or explanted.Per the facility, the complainant part is not expected to be returned for manufacture review/investigation.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 the middle posterior hole would not lock upon insertion of a locking screw in the distal portion of a 3.7mm variable angle locking compression plate (va-lcp) during a bimalleolar ankle fracture repair procedure on (b)(6) 2016.A second screw was attempted without success; the hole was re-drilled on a different angle, but the screw would still not lock.Screw fixation on the hole was abandoned and the surgery was completed as normal.A three (3) minute surgical delay resulted, but the patient¿s postoperative status/outcome was reported as ¿fine.¿ this report is 2 of 2 for (b)(4).

• 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 (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5486246
• MDR Text Key: 39881298
• Report Number: 2520274-2016-11528
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 02/19/2016
• 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 Age: 27 YR