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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM PLATE, FIXATION, BONE

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SYNTHES GMBH 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.107.302
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Manufacturer Narrative
Additional 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during implantation of a left olecranon with 2 holes plate, the surgeon proceeded to place the screws that go to the olecranon head which locks in variable angle of 4 screws, but only 1 is locked. Surgeon verified surgical technique several times; however this failure continues to persist. It was observed that when the screw was placed, it jumped whenever it came into contact with the plate and did not lock to it. The screw heads were damaged. Thus the 4-hole plate was used and the screws were locked with no further issues. The procedure was delayed for a few minutes. There was no patient impact. This report is for one (1) 2. 7mm/3. 5mm va-lcp olecranon pl 2h/lt/90mm. This is report 1 of 4 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during implantation of a left olecranon with 2 holes plate, the surgeon proceeded to place the screws that go to the olecranon head which locks in variable angle of 4 screws, but only 1 is locked. Surgeon verified surgical technique several times; however this failure continues to persist. It was observed that when the screw was placed, it jumped whenever it came into contact with the plate and did not lock to it. The screw heads were damaged. Thus the 4-hole plate was used and the screws were locked with no further issues. The procedure was delayed for a few minutes. There was no patient impact. This report is for one (1) 2. 7mm/3. 5mm va-lcp olecranon pl 2h/lt/90mm. This is report 1 of 4 for complaint (b)(4).
 
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Brand Name2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13213514
MDR Text Key286334654
Report Number8030965-2022-00217
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.107.302
Device Lot Number62P2344
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/10/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWS: LOCKING (QTY 3)
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