MAUDE Adverse Event Report: SYNTHES ELMIRA 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/RIGHT; PLATE,FIXATION,BONE

Catalog Number 02.211.232

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of device breakage and non-union is not known.Additional device product code: hwc.(b)(4) lot number unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a revision surgery occurred on (b)(6) 2017 due to non-union and plate breakage of a metatarsophalangeal (mtp) joint fusion (mpj).Non-union and device breakage was determined on an unknown date during a postoperative appointment.A broken plate, five (5) 2.7 mm intact variable angle (va) locking screws, and one (1) 2.7 mm intact cortex screws were removed.No surgical delay reported.All broken fragments were removed.No additional medical intervention required.The procedure was completed successfully.Patient was revised with new hardware.The initial procedure for mpj repair occurred (b)(6) 2016.Concomitant devices reported: 2.7 mm va lckng screw (part 02.211.010, lot number unknown, quantity 1), 2.7 mm va lckng screw (part 02.211.012, lot number unknown, quantity 1), 2.7 mm va lckng screw (part 02.211.014, lot number unknown, quantity 1), 2.7 mm va lckng screw (part 02.211.016, lot number unknown, quantity 2), 2.7 mm cortex screw (part 202.878, lot number unknown, quantity 1) this report is for one (1) 2.4/2.7 mm va lcp first mtp fusion plate this is report 1 of 1 for (b)(4).

• Brand Name: 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/RIGHT
• 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: 6692511
• MDR Text Key: 79249058
• Report Number: 3003506883-2017-10130
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100776
• 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
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• 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
• Treatment: CORTEX SCREW (202.878, LOT UNKNOWN, QTY 1); LOCKING SCREW (02.211.010, LOT UNKNOWN, QTY 1); LOCKING SCREW (02.211.012, LOT UNKNOWN, QTY 1); LOCKING SCREW (02.211.014, LOT UNKNOWN, QTY 1); LOCKING SCREW (02.211.016, LOT UNKNOWN, QTY 2)
• Patient Outcome(s): Required Intervention
• Patient Weight: 70