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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM VA-LCP LAT DSTL HUM PL 2H/LT/82MM MED-STER; PLATE, FIXATION, BONE

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SYNTHES GMBH 2.7MM/3.5MM VA-LCP LAT DSTL HUM PL 2H/LT/82MM MED-STER; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.117.902S
Device Problem Material Deformation (2976)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/29/2022
Event Type  Injury  
Manufacturer Narrative
Additional narrative: explant date: devices were not explanted but a revision is expected.Complainant part is not expected to be returned for manufacturer review/investigation.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.(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 france as follows: it was reported on (b)(6) 2022 there was lack of locking of 2.7 mm locking screws in two (2) low compression plate (lcp) elbow plates with a dynamometric screwdriver intraoperatively.Several screws bent and there were two (2) edges on one side.The patient was immobilized for ten (10) days and x-rays were taken.A surgical revision is planned to remove everything but has not yet been completed.Implants are still currently implanted in the patient.This is report 2 of 12 for (b)(4).This report is for a 2.7mm lcp plate.
 
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.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received regarding the event.It was reported that there was unlocking of the screw relative to the plate and retraction of the screws.It was reported that the customer encountered an incident with the 2 lcp plates.It was reported that the implant had been in the patient for 10 days.It was reported that there was a cast immobilization.Investigation summary = product was not returned.Based on the information available, it has been determined that no corrective and 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 history review =part # 02.117.902s, lot # h615993, manufacturing site: werk selzach, release to warehouse date: 19 apr2018, expiration date: 01 apr2028, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.
 
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Brand Name
2.7MM/3.5MM VA-LCP LAT DSTL HUM PL 2H/LT/82MM MED-STER
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ   2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14949156
MDR Text Key295451988
Report Number8030965-2022-04632
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819506114
UDI-Public(01)07611819506114
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.117.902S
Device Lot NumberH615993
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/24/2022
Initial Date FDA Received07/07/2022
Supplement Dates Manufacturer Received08/02/2022
Supplement Dates FDA Received08/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2018
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
LOCKSCR ø3.5 SELF-TAP L22 SST; LOCKSCR ø3.5 SELF-TAP L22 SST; LOCKSCR ø3.5 SELF-TAP L26 SST; VA LOCKING SCREW STARDRIVE; VA LOCKING SCREW STARDRIVE® à 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® à 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® à 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® à 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® à 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® à 2.7 MM (HE; VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108
Patient Outcome(s) Required Intervention;
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