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

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

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032)

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.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 india as follows: this report is being filed after the review of the following journal article: bhattacharyya, a.Et al.(2011), operative management of closed intra-articular fractures of distal end of humerus in adults, journal of indian medical association, vol.109, pages 418-423 (india).The aim of this study is to report the operative management of closed intra-articular fractures of distal end of humerus in adults.A total of 60 patients with distal humerus of ao type c underwent open reduction and internal fixation through transolecranon approach.There were 45 males and 15 females with mean age of 38 years.The implants used were 1/3 tubular plate and 3.5 mm dynamic compression plate (dcp) or recon plate.Minimum follow-up was of 1 year duration with average follow-up of 3 years.The following complications were reported as follows: 26 patients had loss of extension of 30 degree or less.15 patients had pain in elbow after prolonged activity.15 patients had ulnar nerve paraesthesia.5 patients had skin complications which healed with repeated dressing.21% of the patients had fair results and 13% had poor results.This report is for an unknown synthes 3.5 mm dcp.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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: 11541606
• MDR Text Key: 254843524
• Report Number: 8030965-2021-02164
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• 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: 02/23/2021
• 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