MAUDE Adverse Event Report: SYNTHES USA; SCREW,FIXATION,BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Date of event: rudge, w., sewell, m., al-hadithy, n., wallace, c., lambert, s.(2015).Shoulder linked arthroplasty in patients with obstetric brachial plexus palsy can improve quality of life and function at short-term follow-up.J.Shoulder elbow surg 24, 1473-1480.This report is for an unknown 3.5mm or 4.5mm cortex screw/quantity, 1/unknown lot.Udi: unknown part number, udi is unavailable.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: rudge, w., sewell, m., al-hadithy, n., wallace, c., lambert, s.(2015).Shoulder linked arthroplasty in patients with obstetric brachial plexus palsy can improve quality of life and function at short-term follow-up.J.Shoulder elbow surg 24, 1473-1480.The purpose of this retrospective study was to determine function and health-related quality of life (hrqol), radiographic findings, and survival and complications after total shoulder arthroplasty (sa) for young patients with obstetric brachial plexus palsy (obpp) and glenohumeral osteoarthritis (oa).The results of nine patients (3 men and 6 women, with a mean age of 29 years, age range 16-56), between 2006 and 2010 who were treated with a linked constrained sa (cadcam glenoid shell and humeral components including four 3.5mm or 4.5mm cortical screws) were reviewed.The patients had undergone a mean of 3 previous shoulder operations (range 2-6).Follow-up was at a mean of 5.1 years (range 2.6-7.6 years).Noted complication included a (b)(6) female patient who required trimming of a prominent glenoid screw and acromioclavicular joint excision at 33 months.This is report 1 of 1 for (b)(4).This report is for an unknown 3.5mm or 4.5mm cortical screw.

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5846407
• MDR Text Key: 51150420
• Report Number: 2520274-2016-13873
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR