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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/RT/75MM-SHORT PLATE, FIXATION, BONE

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SYNTHES GMBH 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/RT/75MM-SHORT PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.117.003
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional device product code: hwc complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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 a patient underwent an open reduction internal fixation (orif) procedure to treat a comminuted right distal humeral fracture. The patient was positioned in lateral decubitus position. After that the surgeon made his incision over the affected elbow and reduced the fracture, he plated the distal humerus first with a medial plate and then posterolateral with an independent 3. 5 cortex screw. When using the right sided 2. 7/3. 5mm variable angle-locking compression plate (va_lcp) posterolateral with extension distal humeral plate, surgeon used the more superior screw holes with one (1) 3. 5 cortex screw to compress the plate to bone. This worked as per surgical technique and the surgeon was happy with the reduction and position of the plate. Surgeon then proceeded to lock the construct and started by drilling for a 2. 7mm variable angle (va) locking screw in the most distal, medial hole in the plate. He went via the surgical technique of inserting the drill guide in the hole, using the 2. 0 mm drill bit and inserting a 22mm locking screw into the screw hole under power with the 1. 2nm torque limiter. However the screw did not torque off when he was inserting the screw slowly under power. He decided to take it out to double-check the screw was a locking screw. Under inspection, there was no thread on the head of the screw. He then tried with 6 other screws in the same screw hole. All had seemingly 'working' double lead screw thread when it loaded on the screwdriver by the nurse but none would engage in the screw hole. After inspecting the screws after the surgeon tried screwing them in, all were burred and unusable. The surgeon could not comment on the screw hole to its condition due to being in situ with blood, soft tissue in the way. He did not want to take it out as he was happy with reduction and taking if off would have increased operating time for the patient and there were no replacement for it. Thus locking screw was unable to be put in. Surgeon had preference to have that used for maximum stability for articulate segment. This report is for one (1) 2. 7mm/3. 5mm va-lcp postlat dhp-lat supt 3h/rt/75mm-short this is report 3 of 9 for complaint (b)(4).

 
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Brand Name2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 3H/RT/75MM-SHORT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12342892
MDR Text Key267311090
Report Number8030965-2021-06862
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK120717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.117.003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/19/2021 Patient Sequence Number: 1
Treatment
2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; UNK - DRILL BITS: TRAUMA; UNK - SCREWDRIVERS; UNK - SCREWS: 3.5 MM CORTEX; UNK - TORQUE DEVICES
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