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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI; WASHER, BOLT NUT

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SYNTHES GMBH WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI; WASHER, BOLT NUT Back to Search Results
Catalog Number 419.990S
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, during the ankle arthrodesis the washer broke while conventional tightening on 7.3 cannulated screws.Procedure was completed successfully with seventy four(74) minutes delay.Concomitant device reported: unk - screws: 6.5/7.3 mm cannulated (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) washer ø13/6.6 f/scr ø4.5-7.3 ti.This is report 1 of 1 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary.The complaint device was not received for investigation.A photo investigation was performed based on the files attached in notes & attachments section of pc titled 'picture 1", "picture 2","picture 3".The images were reviewed, and the complaint is confirmed, the image shows the washer broken.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - a manufacturing record evaluation was performed for the finished device 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.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Additional event information: the surgery was completed successfully with 30-minutes delay.There was no additional medical intervention required.There were no fragments are retained in the patient.The patient outcome was stable.
 
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Brand Name
WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI
Type of Device
WASHER, BOLT NUT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ   3942
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12720691
MDR Text Key285170103
Report Number8030965-2021-09129
Device Sequence Number1
Product Code HTN
UDI-Device Identifier07611819270046
UDI-Public(01)07611819270046
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number419.990S
Device Lot Number184P321
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/20/2021
Initial Date FDA Received10/29/2021
Supplement Dates Manufacturer Received11/15/2021
12/30/2021
Supplement Dates FDA Received11/18/2021
12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED
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