MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LOCKING: FEMORAL; PLATE, FIXATION, BONE

Catalog Number UNK - PLATES: LOCKING: FEMORAL

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

Patient Problems Deformity/ Disfigurement (2360); Thrombosis/Thrombus (4440); Physical Asymmetry (4573)

Event Date 01/01/2016

Event Type  Injury  

Event Description

This is report 1 of 6 for (b)(4).This report is being filed after the review of the following journal article: liu s., xia y., kang y., wei x., (2016) the effect comparison between two operation methods for treatment of intertrochanteric fractures in the elderly (china).This study aims to investigate the effect of the two kinds of internal fixation methods for treatment of intertrochanteric fractures in the elderly.From march 2011 to march 2016, 93 elderly patients (38 males and 55 females) aged 60 to 88 years with intertrochanteric fractures were treated with screw-plate system [femoral locking plate and dynamic hip screw (dhs)] and intramedullary fixation system [femoral antirotation intramedullary nail (pfna)].The patients were divided into two groups according to different treatment methods: screw-plate system group: 42 cases, 15 males and 27 females, aged 60 ~ 79 (67.4 ± 5.5) years.Pfna group: 51 cases, 23 males and 28 females, aged 65 ~ 88 (68.4 ± 3.6) years.All patients were followed up for 6 to 24 months.The following complications were reported as follows: screw-plate system group: limb shortening in 7 cases, hip varus in 7 cases, deep venous thrombosis in 1 case, harris scores: 3 cases were poor.Internal fixation fracture in 2 cases.Plate breakage resulted from ambulation with weight bearing 2 months after surgery.Pfna group: limb shortening in 2 cases.Hip varus in 1.Harris scores: 2 cases were poor.This report is for unknown synthes screw-plate system [femoral locking plate and dynamic hip screw (dhs)] and unknown synthes intramedullary fixation system [femoral antirotation intramedullary nail (pfna)].

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown device/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.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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.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.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: UNK - PLATES: LOCKING: FEMORAL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14756411
• MDR Text Key: 295033087
• Report Number: 8030965-2022-04180
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PLATES: LOCKING: FEMORAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention