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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM PLATE,FIXATION,BONE

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SYNTHES ELMIRA LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM PLATE,FIXATION,BONE Back to Search Results
Catalog Number 241.381
Device Problem Bent (1059)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Updated complaint information. Device is not expected to be returned for manufacturer review/investigation. Device 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
On 14-jul-2017: part data was added to complaint with an alert date of (b)(6) 2017, per a follow-up from the sales consultant stating that the screws were not known to be bent until it was discovered during the revision on (b)(6) 2017. This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
Part# and (b)(4), lot number unknown. Device is not expected to be returned for manufacturer review/investigation. 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
It was discovered on (b)(6)2017, during the surgery, that two (2) screws were bent since the patient continued to ambulate with a broken plate. The lateral side has the 1/3 tubular plate, the 4. 0 screws were removed and the lateral 1/3 tubular plate was left in the patient. The surgeon placed a wound vacuum (vac) on the patient since patient is diabetic. The need for a wound vac is indicative of a post-operative infection. No new hardware was implanted. A follow-up surgery was scheduled for (b)(6)2017. However, since the wound vac was still draining on (b)(6)2017 the second surgery was postponed to (b)(6)2017. The second surgery on (b)(6)2017 involved implantation of locking compression (lcp) distal fibula plates, a (b)(4) was used on the medial side of the tibia, and medial 35mm lcp hook plates placed to cover up the (b)(4). There was no surgical delay and no other complications reported for both revisions. The patient outcome was reported as stable, and the surgeon will monitor the patient's status. Reportedly, it is unsure if another revision will be required.
 
Manufacturer Narrative
Date of event is unknown. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. This report is for one (1) unknown 1/3in tubular plate. Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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
It was reported that a patient underwent a tri-malleolar fracture repair on (b)(6) 2017. The surgeon ordered patient non-weight bearing postoperatively. The patient was non-compliant and the nurse allowed the patient to ambulate. This caused the 1/3in tubular plate to bend. Revision surgery was scheduled on (b)(6) 2017. On (b)(6) 2017, it was reported that patient underwent revision surgery on (b)(6) 2017. During the revision surgery, the hardware was removed and a wound vacuum was placed on the patient. A follow-up surgery was scheduled for (b)(6) 2017. It is unknown if the follow-up surgery was completed as scheduled. Patient and surgery outcome were not reported. This report is for one (1) unknown 1/3in tubular plate. This is report 1 of 1 for (b)(4).
 
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Brand NameLCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6705416
MDR Text Key113921816
Report Number2520274-2017-11927
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number241.381
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 Received06/29/2017
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: 07/12/2017 Patient Sequence Number: 1
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