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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø2.4 SELF-TAP L14 TAN PLATE, FIXATION, BONE

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SYNTHES GMBH LOCKSCR Ø2.4 SELF-TAP L14 TAN PLATE, FIXATION, BONE Back to Search Results
Catalog Number 412.814S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent radial head osteosynthesis for the fracture of the radial head and neck with the locking screw. The surgeon inserted the locking screw with a torque limiter, however he could not tighten it. It was confirmed that the locking screw penetrate the plate hole. Although the surgeon tried to remove the locking screw, he could not remove and left the locking screw in the body. Other locking screws were inserted into plate holes properly. Fixation was deemed to be no problem, and there were no plans for removal surgery. Procedure was completed successfully with thirty(30) minutes of surgical delay. The surgeon commented that the drill guide was attached to plate holes without any problems, and the penetration was caused by the locking screw, not the plate. Concomitant device reported: unk screwdrivers: trauma (part# unknown; lot# unknown; quantity: 1). Unk - plates: lcp radial head (part# unknown; lot# unknown; quantity: 1). Unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: 1). This report is for one (1) lockscr ø2. 4 self-tap l14 tan. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameLOCKSCR Ø2.4 SELF-TAP L14 TAN
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13506841
MDR Text Key288897118
Report Number8030965-2022-00813
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number412.814S
Device Lot Number181P688
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/10/2022 Patient Sequence Number: 1
Treatment
UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - PLATES: LCP RADIAL HEAD; UNK - SCREWDRIVERS
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