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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.037.026
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A product investigation was conducted. Visual inspection: the connecting screw f/tfna helical blade/screw (part #: 03. 037. 026, lot #: 3l63840) was received at us cq. Upon visual inspection, the threaded portion at the midshaft revealed torn thread. Dimensional inspection: no dimension inspection was performed as there was no damage that warranted a dimensional inspection. Document/specification review: relevant. Drawing was reviewed. No design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed as the visual inspection revealed torn thread at the mid-shaft area. No definitive root cause could be determined based on the provided information. No new, unique or different patient harms were identified as a result of this evaluation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. A device history record (dhr) review was conducted: part # 03. 037. 026, synthes lot # 3l63840, release to warehouse date: 14 may 2019, manufacturer: (b)(4), no ncr's were generated during production. 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 an unknown date during a set up for the procedure it was noticed that the thread on the helical blade/screw coupling screw was damaged and unable to be used. Surgeon chose to swap to different nail system. There was a brief surgical delay as another set was opened. During manufacturer's investigation of the returned device on (b)(6) 2021, it was observed that the threaded portion at the midshaft revealed torn thread. This report is for one (1) helical blade/screw coupling screw. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameHELICAL BLADE/SCREW COUPLING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12061014
MDR Text Key268257373
Report Number8030965-2021-05309
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.026
Device Lot Number3L63840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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