MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: stodle ah, et al.(2020), temporary bridge plating vs primary arthrodesis of the first tarsometatarsal joint in lisfranc injuries: randomized controlled trial, foot & ankle international, volume 41 (8), page 901-910, ((b)(6)).This study compared primary arthrodesis of the first tarsometatarsal (tmt) joint to temporary bridge plating in unstable lisfranc injuries.From october 2011 to august 2015, 48 patients with acute lisfranc injury were included in the study and followed for 2 years.24 patients were randomized to primary arthrodesis (pa) of the medial 3 tmt joints, whereas 24 patients were randomized to temporary bridge plate (bp) over the first tmt joint and primary arthrodesis of the second and third tmt joints.In the pa group, there were 11 males and 13 females with a mean age of 30 years (range, 23-40 years).In the bp group, there were 11 males and 13 females with a mean age of 34 years (range, 28-40 years).In the bp group, the first tmt joint was bridge with an unknown synthes 2.7mm locking plate, while in the pa group, the group the arthrodesis of the first tmt joint was fixed with 2 unknown 2.7- or 3.5-mm fully threaded screws with interfragmentary compression.The primary arthrodesis of the second and third tmt joints was either fixed using an unknown 2.7- or 3.5-mm fully threaded screws or, in case of a severely comminuted joint, a locking plate was used.Postoperatively, the patients remained non¿weight bearing for the first 6-8 weeks.The patients had a short leg splint that was removed at 2-3 weeks together with the sutures, and a short leg cast was applied.The patients then started weight-bearing as tolerated in a walker boot, which was used during weight-bearing until 12 weeks after surgery.In the bp group, the dorsal bridge plate over the first tmt joint was removed 4-5 months after surgery.The patients returned for follow-up at 2-3 weeks, 6-8 weeks,12 weeks, 6 months, 1 and 2 years postoperatively.Complications were reported as follows: 11 patients had radiographic osteoarthritis in the first tarsometatarsal joint.1 of these patients required conversion to arthrodesis of the first tarsometatarsal joint at 24 months because of painful osteoarthritis.1 patient had superficial wound infection treated successfully with oral antibiotics.2 patients had developed complex regional pain syndrome.1 patient had loosening of a screw from the plate, which led to a rupture of the extensor hallucis longus tendon.The patient was treated with a transfer of the second toe extensor digitorum longus to extensor hallucis longus with an excellent outcome.2 patients had nonunion in the third tarsometatarsal joint.5 patients had hardware removed in addition to the planned removal of the bridge plate.This report is for the unknown synthes 2.7mm locking plate.This is report 1 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10562474
• MDR Text Key: 215524916
• Report Number: 8030965-2020-07268
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2020
• 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