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

Catalog Number 241.381

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

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).

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.

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM
• Type of Device: PLATE,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 Key: 6705416
• MDR Text Key: 79755985
• Report Number: 2520274-2017-11927
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 241.381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention