MAUDE Adverse Event Report: SYNTHES MONUMENT 20MM COCR RADIAL HEAD 2MM HT EXTENSION/14.0MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.220S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device broke intra-operatively and was not fully implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).In addition, there was a thirty minute surgical delay and additional unanticipated x-rays had to be taken.Device history record review for part #: 09.402.220s, lot#: 7683418 (sterile).20mm cocr radial head 2mm ht extension/14.0mm-sterile: manufactured by : (b)(4), packaged by: (b)(4), manufacturing date: 29-aug-2014, expiration date: 30-jun-2019: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 that a radial head set screw broke in half as it was torqued down during a right radial head replacement procedure on (b)(6) 2016.As the surgeon torqued the set screw, the head broke off, breaking just underneath the head where it connects to the shaft.The broken set screw head fragment was easily retrieved.It was confirmed that no fragments remained in the patient.The broken set screw shaft remained embedded in the stem.Since the surgeon was then unable to remove the radial head from the stem, the entire construct was removed and replaced with a new larger diameter implant.There was a reported approximate 30 minute surgical delay and additional x-rays were required.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: radial stem (part #04.402.007s, lot #h071071, quantity (b)(4)), torque limiting attachment (part #03.110.002, lot #7640, quantity (b)(4)).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the radial head (part number 09.402.220s, lot number 7607089).The subject device was returned with the complaint condition stating the returned radial head has a broken set screw.The screw head is sheared off of the shaft, and the shaft remains inside the radial head.The radial head is stuck to the radial stem and cannot be removed.The device has some minor wear.The complaint is confirmed.A visual inspection, complaint history review, drawing review, device history review and risk assessment review were performed as part of this investigation.Drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.The shaft of the radial head set screw was unable to be measured as it is stuck inside the radial head.No definitive root cause was able to be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 20MM COCR RADIAL HEAD 2MM HT EXTENSION/14.0MM-STER
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6103341
• MDR Text Key: 59968114
• Report Number: 1719045-2016-10828
• Device Sequence Number: 1
• Product Code: KWI
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 09.402.220S
• Device Lot Number: 7607089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE RADIAL STEM (PART #04.402.007S); TORQUE LIMITING ATTACHMENT (PART #03.110.002)
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR