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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 40MM; PLATE,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 40MM; PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.211.040S
Device Problem Break (1069)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 08/17/2020
Event Type  Injury  
Manufacturer Narrative
Additional procode: hwc.(b)(4).The device was 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent a surgery for distal humerus with the screw in question.During the surgery, after the surgeon inserted the screw halfway with a power tool, the surgeon tried to insert the screw completely with a screwdriver, but he could not turn the screw.The surgeon confirmed by image intensifier that the tip of the screw was out of the bone.He tried to remove it but the screw was not turned because the screw was idling and there was a cracking sound.While touching the tip of the screw the surgeon turned the screw with the screwdriver, but the tip of the screw was not turned.When the surgeon removed the screwdriver, only the screw head was held with the screwdriver, and the screw shaft remained in the bone.The surgeon removed the screw shaft with the kochel forceps.The surgery was completed successfully with a thirty (30) minute delay.No further information is available.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity 1), unknown power tool device (part # unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity unknown), unknown plate (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 40mm.This is report 1 of 1 for (b)(4).
 
Event Description
Updated event description: patient outcome was stable.
 
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.
 
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 investigation selection investigation site: cq zuchwil selected flow: damage.Visual inspection: the screw was found broken between the shaft and the screw-head.Moreover, the threaded shaft was is slightly bent.The anodized layer is worn away at the damages which indicates that they were caused post-manufacturing.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents, the correct material (tan) was used according iso 5832-11.Conclusion: our investigation has shown that the complaint condition for the broken screw is confirmed due to the received part.Because of the damage, it is not possible to measure the relevant dimension.During the performed evaluation no manufacturing related issue could be detected.Based on the provided information we are not able to determine the exact cause of this breakage.While no definitive root cause could be determined based on the received information, it is likely that during insertion, the screw encountered unintended forces, such as excessive force application which finally resulted in the breakage.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 history lot sterile part: part: 04.211.040s, lot: 6l53573, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: dec 20, 2019, expiry date: dec 1, 2029.Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Part number:04.211.040, synthes lot number: 23p1097, supplier lot number: n/a, release to warehouse date: oct 18, 2019 , expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 40MM
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10524824
MDR Text Key212125359
Report Number8030965-2020-06877
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819444263
UDI-Public(01)07611819444263
Combination Product (y/n)N
PMA/PMN Number
K100776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.211.040S
Device Lot Number6L53573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Date Manufacturer Received10/15/2020
Patient Sequence Number1
Treatment
UNK - PLATES; UNK - POWER TOOL DEVICE; UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
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