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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L12 TA PLATE, FIXATION, BONE

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SYNTHES GMBH VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L12 TA PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.211.012S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
Event Type  malfunction  
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 an open reduction internal fixation surgery for olecranon fracture with the plate in question. When the surgeon tried to insert a screw into the proximal screw hole of the plate, the screw idled and could not lock the plate. The surgeon tried to insert other different sizes of screws from another angle into the same screw hole, but those screws could not lock the plate either. Other screw holes of the plate were locked with screws with any problems. The surgeon concluded that there was no problem with the fixation of the fracture and ended the surgery with the screw hole in question left empty. Procedure was completed successfully with thirty(30) minutes of surgical delay. Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1). This report is for one (1) va lockscr ø2. 7 head 2. 4 self-tap l12 ta. This is report 3 of 4 for complaint (b)(4).
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. If additional information is made available, the investigation will be updated as applicable. 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.
 
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Brand NameVA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L12 TA
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13515997
MDR Text Key290549355
Report Number8030965-2022-00847
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.211.012S
Device Lot Number8L79118
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWDRIVERS; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA; VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN
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