MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 24MM COCR RADIAL HEAD 4MM HT EXTENSION/17.0MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 09.402.424S

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient age, date of birth, and weight not available for reporting.Date of device loosening is not known.Device has not yet been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter address not available for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported patient underwent initial surgery on (b)(6) 2016 for treatment of a closed proximal displaced fracture head of the left radius.Patient was implanted with one (1) 8 mm straight radial stem 28 mm and one (1) 24 mm radial head 4 mm height extension/17.0 mm.On (b)(6) 2017 during a postoperative follow up visit, patient presented with pain and loosening of hardware.Revision surgery has been scheduled for some time in (b)(6) 2017.No further information is available at this time.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device: manufacturing location: (b)(4).Packaged by: (b)(4).Manufacturing date: 21-oct-2014 expiration date: 30-sep-2019.Part #: 09.402.424s, lot#: 7608133 (sterile) - 20mm cocr radial head 4mm ht extension/17.0mm - sterile.Quantity 75.Component parts reviewed: part 21022 lot 5317556, material testing for titanium for implant material, product certification received from dynamet meet specification.Raw material (ti) inspection sheet meet specification.Raw material receiving/putaway checklist meet requirements.Part 41060 lot 7695678, raw material received from carpenter technology.Certificate of tests received from carpenter meet specification.Raw material receiving/putaway checklist meet requirements.Avalign certificate of compliance meet specification.Inspection sheet for incoming final inspection met inspection acceptance criteria.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterigenics (corona), ¿sterility documentation was reviewed and determined to be conforming.¿ no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: 24MM COCR RADIAL HEAD 4MM HT EXTENSION/17.0MM-STER
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7087233
• MDR Text Key: 93866097
• Report Number: 2939274-2017-50159
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982132727
• UDI-Public: (01)10886982132727(17)190930(10)7608133
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 09.402.424S
• Device Catalogue Number: 09.402.424S
• Device Lot Number: 7608133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Date Device Manufactured: 10/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention