MAUDE Adverse Event Report: SYNTHES USA 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; PLATE, FIXATION, BONE

Catalog Number 02.211.012

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient initials are (b)(6).Patient weight is unknown.Additional product codes for this report include hwc.(b)(4).Only one (1) of the two reported screws was left implanted in the patient.The other screw was inserted then removed due to the reported event.The fields, therefore, have been left blank due to lack of information/verification.The complainant part is not expected to be returned for manufacturer 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 a distal screw would not engage the plate during an ankle trauma procedure on (b)(6) 2016.In preparation for the distal screw, the surgeon appropriately engaged the drill guide, drilled through the guide and plate, and measured through plate.When the distal screw was inserted, the head was supposed to lock into the plate, but it did not engage.The first screw was removed and another distal screw (same part number) was used, but the same issue was encountered.Both screws malfunctioned and spun inside the plate hole.The surgeon was concerned it would back out, but decided to leave the second screw implanted in the patient regardless.The patient was closed up.A potential need for revision surgery exists, but nothing is scheduled at this time.A one (1) to two (2) minute surgical delay occurred due to the reported event.The patient's status post-surgery is unknown.The procedure was completed successfully.This report is 1 of 3 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
• 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: 5447825
• MDR Text Key: 38647278
• Report Number: 2520274-2016-11160
• 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: Other
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• 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: 50 YR