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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
Model Number 03.037.010
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: a device history record (dhr) review was conducted: visual inspection: the cannulated connecting screw (p/n: 03. 037. 010, lot #: 58p8814) was returned and received for analysis. Upon visual inspection, the threaded tip of the device is slightly peeled. No other issues were observed with the returned device. Dimensional inspection: a dimensional inspection cannot be performed due to post manufacturing damage. Complaint confirmed: yes, the complaint can be confirmed based on the available information. Investigation conclusion: the reported condition of the complaint device (cannulated connecting screw) is confirmed as the threads are peeled. 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 preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot - part number: 03. 037. 010, lot number: 58p8814, manufacturing site: (b)(4), release to warehouse date: 16-july-2020. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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, the cannulated screw was bent and was hard to connect to nail. Concomitant device reported: unk - nails (part# unknown; lot# unknown; quality:1). This report is for one (1) cannulated connecting screw. This is report 1 of 1 for complaint (b)(4).
 
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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 Key13593168
MDR Text Key286470041
Report Number8030965-2022-01123
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131548
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.010
Device Catalogue Number03.037.010
Device Lot Number58P8814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2020
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: 02/24/2022 Patient Sequence Number: 1
Treatment
UNK - NAILS
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