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

Catalog Number UNK - CONSTRUCTS: LCP RECONSTR

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

Patient Problems Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: bech, n.H.And kloen, p.(2022), failed medial buttress plating of a femoral neck fracture salvaged with a pauwels osteotomy: case report and review of literature, trauma case reports, vol.37 (100569), pages 1-4 (netherlands).The aim of this case report is to describe the literature on medial buttress plating of the femoral neck fracture and to present two salvages of our early failures.A total of 2 young patients who were treated with cannulated screws and the addition of an anteromedial buttress plate on the femoral neck were included in the study.A (b)(6) male sustained an ao 31b2.3 fracture of the left hip (pauwels type 3 fracture; fig.1) due to fall with a moped.The fracture was fixated with three 7.3 mm fully threaded cannulated screws with washers (unknown manufacturer) and a 6-hole 3.5 mm titanium reconstruction lcp plate (depuy synthes, amersfoort, the netherlands).The plate was contoured and positioned on the anteromedial side of the femoral neck; between the 5 and 6 o'clock position.When testing the hip prior to closure an audible clicking was noted on flexion and rotation of the hip.We thought the posterior cannulated screw was malpositioned with its middle section posteriorly outside of the neck.However, after removing this screw, the click persisted.We noticed that the proximal end of the anteromedial buttress plate was impinging on the acetabulum.The plate was removed and replaced by a shorter plate (4-hole; unknown manufacturer), more distal and medial.The posterior cannulated screw was not replaced because we were not sure if it had been malpositioned.Replacing it in a more anterior position was tried but the guidewire (unknown) kept slipping into the prior entry point.We felt the fixation with 2 screws and a plate was strong enough.He started toe-touch weightbearing for 6 weeks.A (b)(6) male sustained an ao 31b2.3 hip fracture (pauwels type 3 fracture; fig.2) in a bicycle accident.A 5-hole lcp reconstruction plate was placed on the anteromedial side of the femoral neck and three partially threaded cannulated screws (7.3 mm) with washers (unknown manufacturer) were inserted.He was toe-touch weightbearing for 6 weeks.Radiographs at 6 weeks suggested bony bridging.He advanced to partial weightbearing at 6 weeks.At 7 months, a ct-scan showed a nonunion (fig.2).An mri at that same time did not show evidence of avascular necrosis.A pauwels' osteotomy was offered.A lateral closing wedge of 20 degrees was removed.A 110-degree angular blade plate (85 mm; unknown) was inserted.At 6 weeks post-operatively, he was partial weight bearing.At 3 months follow up he was fully weight bearing.At 21 months he returned for a follow-up visit.He was pain-free with full range of motion with excellent outcome scores (nrs 1, hhs 94).Radiographs showed consolidation (fig.2), brooker grade 1 heterotopic ossification without avascular necrosis or arthrosis.This report is for an unknown synthes 3.5 mm lcp reconstruction plate and unknown synthes lcp reconstruction plate/screws constructs.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - plates: lcp reconstruction.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

This report is for an unk - plates: 3.5 mm lcp reconstruction/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary :product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.

• Brand Name: UNK - CONSTRUCTS: LCP RECONSTRUCTION PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13604141
• MDR Text Key: 288796108
• Report Number: 8030965-2022-01162
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: LCP RECONSTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male