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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI MULTILOC SCREW LENGTH 50MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI MULTILOC SCREW LENGTH 50MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.019.050
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 08/29/2020
Event Type  Injury  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 during a humerus open reduction internal fixation (orif) procedure on (b)(6) 2020 the screws for humeral nail missed the nail.The team burnt one of the multiloc screws trying to remove it (damaged thread) and also opened another nail to test the system.It was noted that the insertion-handle may be damaged.One of the pieces that attached the insertion handle to the jig/aiming arms is damaged/not present.This caused ¿give¿ in the jig and meant that the targeting sleeves did not completely align.The procedure was completed successfully with a surgical delay of 45 minutes.The procedure was completed by using another instrument to help fix the jig and connection piece together.This was held steadily by surgeon and assistants.This is report 1 of 8 for (b)(4).
 
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.H3, h4, h6: part 04.019.050, lot 38p3230: manufacturing site: grenchen.Release to warehouse date: january 20, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: one lockscrew and one multiloc screw were received back for investigation.Both screws were found jammed together.It is not possible to detach the devices from each other.There are slightly signs of use overall on the surfaces visible.The screw recess is intact.All features related to the reported complaint condition were reviewed and no other issues were identified.A functional test as well as a dimensional test is not appropriate, since all complaint-relevant dimensions cannot be checked/ measured due to the "jammed" condition.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The complaint is confirmed as the device was received in a jammed condition.While no definitive root cause could be determined it can be assumed that multiple factors could have lead to the jamming, such as alignment issues and/ or excessive force/ torque application.During the investigation, no product design or manufacturing issues were observed 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
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.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
This is report 8 of 8 for (b)(4).
 
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Brand Name
4.5MM TI MULTILOC SCREW LENGTH 50MM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10725803
MDR Text Key212711858
Report Number8030965-2020-08130
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819426580
UDI-Public(01)07611819426580
Combination Product (y/n)N
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.019.050
Device Lot Number38P3230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Date Manufacturer Received11/05/2020
Patient Sequence Number1
Treatment
AIM-ARM LAT F/ML PHN; INSERT-HANDLE F/ML HUM NAIL; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - INSERTION INSTRUMENTS: CONNECTING SCREW; UNK - NAILS: HUMERAL; UNK - SCREWS: TRAUMA; AIM-ARM LAT F/ML PHN; INSERT-HANDLE F/ML HUM NAIL; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - INSERTION INSTRUMENTS: CONNECTING SCREW; UNK - NAILS: HUMERAL; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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