MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 2.7 MM LCP; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D1, d2, d3, d4, g4-510k: this report is for an 2.7 mm locking plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.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.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

This report is being filed after the review of the following journal article: poulsen, m., stødle, h., nordsletten, l.And röhrl, s.M.(2022), does temporary bridge plate fixation preserve joint motion after an unstable lisfranc injury?, foot and ankle surgery, vol.29 (xx), pages 151-157.(norway).The aim of this study was to answer key questions regarding treating unstable lisfranc injury with a joint-sparing osteosynthesis.Firstly, is 1st tmt joint motion preserved after temporary fixation with an extra-articular bridge plate.And if so, does the retained movement correlate with the clinical and radiological outcome over time.A total 10 patients (5 females and 5 males) with an unstable lisfranc injury were included.All were treated with a dorsal bridge plate over the 1st tmt joint and primary arthrodesis of the 2nd and 3rd tmt joints.Inclusion criteria were acute lisfranc injuries with instability of the medial 3 tmt joints and no fractures to the 1st tmt joint.A joint displaying > 2 mm of dislocation in any direction compared to the opposite foot during a fluoroscopic, abduction stress-test, or preoperative ct/radiographs, was considered unstable.The main surgical goal was to achieve anatomic reduction and stability of the lisfranc-joints.A 2- incision technique was used with a dorsomedial approach over the 1st tmt joint and a dorsolateral approach over the 3rd tmt joint.Perioperatively, anatomic reduction was confirmed with fluoroscopy.The extra-articular bridging plate fixation of the 1st tmt joint was done with a dorsomedial 2.7 mm locking plate (lcp compact foot 2.4/2.7; depuy synthes, oberdorf, switzerland).As all included cases had instability of the 2nd and 3rd tmt joints, an arthrodesis was performed in these joints with either screws or plate fixation.No patients had displacement in the 4th and 5th tmt joints after stabilization of the medial 3 tmt joints, hence no fixation of the lateral column was required.Finally, all patients received a ¿homerun¿ screw inserted from the 1st cuneiform to the base of the 2nd metatarsal bone.The median follow-up was 70.4 months (7.4 sd; 62 ¿ 83).The following complications were reported as follows: due to symptoms, uncertain of chronic infection and functional limitations, the patient was keen for the removal of the surgical implants.During the removal of the metal implants from the fourth and fifth metacarpals by the senior author who is classified as an expert according to the tang and giddings¿ classification,7 an incision over the healed scar was made with dissection down to the implants.Inflammatory changes to the tissues from the skin to the depth of the implants with some areas of necrosis were found.Marked tenosynovitis of the extensor tendons and fibrotic scarring, with visibly darkened particulate matter, was seen.Osteoarthritis on radaiography: patient 3, 4, 7 and 8 had dorsal osteophyte showed on radiological findings 1 year post-operatively while patient 5 had joint space narrowing subchondral sclerosis 1 year post-operatively.Patient 3 had dorsal osteophyte and joint space narrowing 5 years post-operatively.Patient 4 had dorsal osteophyte and subchondral sclerosis 5 years post-operatively.Patient 5 had joint space narrowing subchondral sclerosis 5 years post-operatively.Patient 8 had dorsal osteophyte 5 years post-operatively.Patient 10 had dorsal osteophyte and subchondral cysts 5 years post-operatively.This report is for an unknown 2.7 mm locking plate (lcp compact foot 2.4/2.7; depuy synthes).A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - PLATES: 2.7 MM LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18633762
• MDR Text Key: 334493293
• Report Number: 8030965-2024-01876
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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: 01/25/2024
• 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