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U.S. Department of Health and Human Services

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

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SYNTHES USA 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM PLATE, FIXATION, BONE Back to Search Results
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).
 
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Brand Name2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
Type of DevicePLATE, 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 Key5447825
MDR Text Key38647278
Report Number2520274-2016-11160
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK103243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.211.012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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