MAUDE Adverse Event Report: SYNTHES TRAUMA SYNTHES (MODULAR FOOT SYSTEM IMPLANT); 6 HOLES, 2.7MM QUARTER TUBULAR PLATE

Catalog Number 242.06

Device Problems Fracture (1260); Implant, removal of (2320); Device Issue (2379)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/29/2015

Event Type  Injury  

Event Description

A (b)(6) female on (b)(6) 2014 underwent right first mtp arthrodesis for recurrent hallux valgus deformity with arthritis by dr (b)(6), as an ambulatory surgery procedure.Following placement of two 3.5 mm crossing screws, the six-hole tubular plate was applied dorsally with two screws proximally and two screws distally.Excellent fixation was noted.Post-operatively, the pt did well, weight-bearing and activities were increased, as tolerated.As of (b)(6) 2014, the pt was to f/u as needed.She next returned on (b)(6) 2015, she had been doing well until two weeks prior when she started to get achiness in the top of her foot and wondered if it was the hardware because shoes wear was difficult.X-rays showed the plate broken.The plan was to remove the hardware, as it looked prominent, and to assess the fusion.The pt underwent removal of the first mp joint hardware and revision of the fusion, as an ambulatory surgery procedure on (b)(6) 2015.Intra-operatively, micro-motion at the joint was noted.New screws and grafton putty were implanted for fixation.The removed hardware was sent to pathology.The histopathology report noted the two pieces of the one metallic plate measured approximately 2cm and 2.6 cm in length, respectively, and six metallic screws.Notes: the (b)(6) has made (b)(4) aware of the issue; dr (b)(6) indicates that the plate broke due to lack of healing/fusion/osseous bridging across the first mtp joint space; it is to be determined whether we can provide the broken plate to synthes for eval.This is pending the pt's decision.

• Brand Name: SYNTHES (MODULAR FOOT SYSTEM IMPLANT)
• Type of Device: 6 HOLES, 2.7MM QUARTER TUBULAR PLATE
• Manufacturer (Section D): SYNTHES TRAUMA; west chester PA 19380
• MDR Report Key: 5191174
• MDR Text Key: 29989480
• Report Number: 5191174
• Device Sequence Number: 1
• Product Code: HRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 242.06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 1X2MM, CAT #202.812,
• Patient Age: 76 YR