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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

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SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL,FIXATION,BONE Back to Search Results
Catalog Number 03.010.440
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 10/18/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that a driving cap/threaded and an insertion handle for suprapatellar could not be disassembled from each other after surgery.The scrub technician attempted to disassemble the devices using a wrench.During the attempt, the threaded portion of the driving cap broke off inside the insertion handle.No patient involvement.This is report number 2 of 2 for complaint (b)(4).
 
Manufacturer Narrative
An investigation summary was performed.Our investigation of the complaint articles has shown that: one driving cap (part # 03.010.523, lot # 8953354) was returned for investigation.The driving cap shows regular use, with hammer marks and gouges on the head of the device consistent with high impact force.The distal threaded tip of the of the driving cap is broken off and was returned stuck in the returned insertion handle (part # 03.010.440, lot # 14-6678).Although the exact cause for the complaint condition could not be determined, the damage appears to be the result of hammering on the device after it was cross threaded or before it was fully seated against the insertion handle and thus deforming the threads.Subsequently, the force necessary to dislodge the weakened driving cap caused the tip to break.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint condition is confirmed.Device 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 Name
INSERTION HANDLE FOR SUPRAPATELLAR
Type of Device
NAIL,FIXATION,BONE
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ   CH2545
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6082770
MDR Text Key59295323
Report Number3000270450-2016-10266
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/18/2016
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 Number03.010.440
Device Lot Number14-6678
Other Device ID Number(01)10886982068828(10)14-6678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/18/2016
Initial Date FDA Received11/07/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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