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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CONNECSCR CANN W/INTERNAL M6X1 THREAD; GUIDE, SURGICAL, INSTRUMENT

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SYNTHES GMBH CONNECSCR CANN W/INTERNAL M6X1 THREAD; GUIDE, SURGICAL, INSTRUMENT Back to Search Results
Catalog Number 03.010.146
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on september 21, 2021 the 4.2 drill bit was used to drill for a distal locking screw, when it comes into contact with the intramedullary nail, the tip wears out, and therefore the drill must be changed for another, in order to continue drilling.After using with the first screw, the interlock screwdriver quickly releases the screw.The tip of the screw was checked, and it seems the tip was bent or worn.After the placement and locking of the nail, the insertion handle is removed together with the connecting screw.Since the access is so complex, there is a bit of difficulty when removing said set due to the angulation.It shows wear in the thread passages of the connection screw, there is no damage or affection to the patient but it may be risky to use it in a future surgery.Concomitant medical products: unknown distal locking screw (part# unknown, lot# unknown, quantity 1), unknown intramedullary nail (part# unknown, lot# unknown, quantity 1), unknown insertion handle (part# unknown, lot# unknown, quantity 1).This report is for one (1) connecter cann w/internal m6x1 thread.This is report 2 of 2 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.H6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image in the email attached in the notes & attachments section of pc titled "source file - novedad".The image was reviewed, and the complaint condition is confirmed.As the physical device was not returned, a functional fit-up test could not be performed and the reported condition of "unable to dissemble" cannot be confirmed.The reported condition of "stripped/worn/twisted/cross threaded" cannot be confirmed due to the photo quality.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an 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 image) 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 - part # 03.010.146, synthes lot # u314622, supplier lot # u314622, release to warehouse date: 28 jun2018, supplier: (b)(4).No ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.
 
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Brand Name
CONNECSCR CANN W/INTERNAL M6X1 THREAD
Type of Device
GUIDE, SURGICAL, INSTRUMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key12660667
MDR Text Key281660208
Report Number8030965-2021-08793
Device Sequence Number1
Product Code FZX
UDI-Device Identifier07611819394445
UDI-Public(01)07611819394445
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/21/2021
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 Number03.010.146
Device Lot NumberU314622
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2021
Initial Date FDA Received10/19/2021
Supplement Dates Manufacturer Received10/21/2021
Supplement Dates FDA Received10/21/2021
Patient Sequence Number1
Treatment
DRILL BIT Ø4.2 CALIBR L145 3FLUTE; INTER-LOCK SCREWDRIVER COMBINED T25/HEXA; UNK - NAIL INSERTION HANDLES; UNK - NAILS; UNK - SCREWS: NAIL DISTAL LOCKING
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