MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP PROXIMAL TIBIA PLATELOW BEND 4H/76MM/LEFT-STER; PLATE,FIXATION,BONE

Catalog Number 02.124.201S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.(b)(4).Date of initial implant procedure is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.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 had a surgery for an unspecified injury on an unknown date in (b)(6) 2017.The patient fell on an unknown date post-operatively and had some pain after the fall.Upon a follow-up x-ray on an unknown date, it was noted that the patient¿s fracture had displaced.A hardware removal of a proximal tibia plate was performed on (b)(6) 2017, due to the patient¿s fracture being displaced.All explanted implants were intact and removed without issues.Once the plate had been removed, the fracture reduced nicely and the procedure was considered a success.There was no time delay or patient harm reported.The patient outcome was reported as good.This report is for one (1) 3.5mm lcp proximal tibia plate.This is report 1 of 2 for com-(b)(4).

Manufacturer Narrative

Additional narrative: (b)(4).A device history record (dhr) review was performed for part 02.124.201, lot h023496: part manufacturing date: 23feb2016, part exp.Date: 31jan2025, manufacturing location: (b)(4).The device history record shows this lot of 3.5mm proximal tibia plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.

• Brand Name: 3.5MM LCP PROXIMAL TIBIA PLATELOW BEND 4H/76MM/LEFT-STER
• 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: 6731412
• MDR Text Key: 80641842
• Report Number: 3003506883-2017-10139
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

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?: No
• Device Operator: Physician
• Device Catalogue Number: 02.124.201S
• Device Lot Number: H023496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/28/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95