MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE,FIXATION,NAIL

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

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: haddon, j., buciuto, r., and johnsen, l.G.(2019), a prospective randomized trial of 100 patients using trochanteric support plates; worth their mettle?, injury, vol.50, pages 733-737 (norway).The purpose of this study is to compare the radiological and clinical results of sliding hip screw (shs) fixation with or without a trochanteric support plate (tsp) on unstable three-or-more-part trochanteric fractures.From 2008 to 2013, a total of 100 patients were included in this study.Patients were randomized nto 2 different groups: with or without tsp supplementation (¿tsp¿ and ¿notsp¿ groups).There were 10 males and 40 females with an average age of 81.9 years in the tsp group while there were 12 males and 38 females with an average age of 82.4 in the notsp group.It should be noted that the first patients were operated with synthes dynamic hip screw and 135 degree plate with a synthes ultsp, when randomized to the tsp group.In 2009 the hospital changed supplier and smith and nephews 135 degree chs with their corresponding tsp was used from then on.The following complications were reported as follows: 13 patients died before the twelve-month follow-up.10 cases had lagscrew movement in the femoral head (movement of caput relative to the collum screw): 6 patients stabilized and healed; 4 patients had cutout; 8 fractures did not heal by 3 months: 4 went on later to heal; 4 had fixation failure within 12 months resulting in a hip arthroplasty; 2 patients had deep infections: 1 patient had dvt; 1 patient had a stroke; 1 patient had pulmonary embolism; 1 patient had ileus.All these events happened within 6 weeks.1 patient had an amputation at 4 months.Tsp: 1mm less subsidence for all unstable fractures; 3mm less subsidence for all fractures where the lateral wall was broken (evans-jensen type 3 and 5); 4mm m less subsidence in the tsp group for subgroup evans-jensen type 3.This report is for an unknown synthes dynamic hip screw.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

This report is for an unknown constructs: dhs/dcs/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.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.

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE,FIXATION,NAIL
• 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: 13602119
• MDR Text Key: 290780435
• Report Number: 8030965-2022-01154
• Device Sequence Number: 1
• Product Code: KTT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/25/2022
• 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