MAUDE Adverse Event Report: SYNTHES (USA) 9MM TI CURVED RADIAL STEM 46MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.029S

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)46).The initial date of implant is unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation and is still implanted in the patient.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history record review could not be completed.The date of manufacture is unknown.(b)(4).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 during planned a removal of hardware on (b)(6) 2017 the radial stem could not be removed.The plan was to remove a screw and plate from a synthes variable angle - locking compression plate (va-lcp) olecranon that appeared to violate the joint surface as well as the removal of a synthes radial head and stem implant.No reason was provided for the radial head and radial stem removal.As the surgeon was removing a screw during the revision, the surgeon stated that the screwdriver he was using was stripped and was unable to remove the hardware.The surgeon switched to a new t8 screwdriver.The screw was easily removed, intact, upon using the new screwdriver.The patient was not revised with a new screw.The radial head implant was removed uneventfully.The surgeon was unable to remove the radial stem implant.Utilizing the inserter/extractor, the surgeon could not remove the stem.He performed an osteotomy on the proximal radius and was still unable to remove the stem using the extractor.The surgeon reinserted the original radial head and concluded the surgery.There was a delay of approximately five (5) minutes due to the reported event.There was no patient harm reported.This complaint addresses the radial stem that could not be removed.Please see related complaint (b)(4) which addresses the need for revision surgery.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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

Concomitant device reported: one (1) radial head (part # 09.402.026s, lot # 7504371).

Manufacturer Narrative

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: 9MM TI CURVED RADIAL STEM 46MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6416428
• MDR Text Key: 70300857
• Report Number: 2520274-2017-10927
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.029S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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
• Patient Age: 51 YR