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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.037.010
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that (b)(6), 2021, one(1) of the two(2) connecting screws in tfa-1 did not lock with a ball hexagonal screwdriver and fell off easily. The remaining connecting screw in tfa-1 will be used in the procedure. This report is for one (1) connecscr f/insertion handle. This is report 1 of 2 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 sales representative. 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 NameCANNULATED CONNECTING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13334379
MDR Text Key290079648
Report Number8030965-2022-00511
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.010
Device Lot Number9667930
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/24/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWDRIVERS: TRAUMA
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