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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BRANDYWINE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE, DEPTH

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SYNTHES BRANDYWINE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS; GAUGE, DEPTH Back to Search Results
Catalog Number 357.402
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: (b)(4) - manufacturing date: april 14, 2010.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.
 
Event Description
It was reported that a locking bolt measuring device for trochanteric fixation nails fell apart during reassembly in sterile processing.The little ball inside that marks the compression and allows for gradual sliding of the sleeve was missing.There was no reported patient or surgical involvement.This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Additional manufacture date 13march2012.A product investigation was completed: the complaint condition of loose is confirmed on both devices as upon visual inspection; it can be seen that the ball bearing on the internal slider on the complaint device is missing.The distal hooked tip of the devices is undamaged.It is unknown what caused the complaint condition, but it is most likely due to wear over the life of the device.Per the technique guide, the 357.402 locking bolt measuring device is an instrument routinely used in the titanium trochanteric fixation nail system to measure locking bolt/screw length.The relevant drawings were reviewed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.It is most likely this failure mode was due to the method of use or damage during sterile processing while in a disassembled state corrected device history record review: manufacturing location: (b)(4).Manufacturing date: 13march2012.Lot should have 6897935.Part: 357.402, lot: 6897935 (non-sterile) - locking bolt measuring device f/trochanteric fixation nails.Lot was release to the warehouse on 14april2010.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
It was reported while re-assembling two locking bolt measuring devices f/trochanteric fixation nails during sterile processing, they fell apart.The little ball inside to mark the compression was missing that makes the sleeve to slide gradually.There was no patient involvement and no procedure.
 
Manufacturer Narrative
(b)(6).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 Name
LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS
Type of Device
GAUGE, DEPTH
Manufacturer (Section D)
SYNTHES BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer (Section G)
SYNTHES BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5201872
MDR Text Key30417144
Report Number2530088-2015-10683
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
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,Followup,Followup
Report Date 10/21/2015
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 Number357.402
Device Lot Number6897935
Other Device ID Number(01)10886982196255(10)6897935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/21/2015
Initial Date FDA Received11/04/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received11/17/2015
12/08/2015
12/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2010
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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