MAUDE Adverse Event Report: SYNTHES (USA) 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.016.034S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery to treat proximal humeral fracture on (b)(6) 2017, the surgeon attempted to drill the distal hole but the nail interfered with two (2) bits and the two (3) associated protection sleeves would not come off and could not be held down.The surgeon attempted the following to complete the procedural step: drilling without pushing sleeve or drill; drilling by pushing the drill when drill interfered with nail; hammered as drill interfered with nail; took inner cylinder off as drill interfered with nail; and pre-drilled using k-wire2.5.All the technique attempts failed so the surgeon gave up inserting a screw in the distal hole of the nail.The surgeon inserted screws in the proximal hole and ascending screw hole and completed the procedure.The surgery was delayed for 15 minutes due to the complaint event.The surgeon was not considered to be successfully completed because the surgeon could not implant a screw in the distal nail hole.The patient¿s postoperative status was reportedly good.Additional medical intervention was not required.Concomitant device: 1x 03.010.064 / lot unk (drillsl 8/3.2 f/03.010.063) 1x 03.019.008 / lot 8519199 (aim-arm lat f/multiloc phn) 1x 03.019.007 / lot 8404292 (connecscr cann f/multiloc hum nail syst) 1x 03.019.006 / lot 8320039 (insert-handle f/multiloc hum nail syst) this report is 1 of 5 for (b)(4).

Manufacturer Narrative

Device remained implanted; as such explant date is not applicable.Previously reported concomitant devices on medwatch report (b)(4) are now determined as the reportable complained devices.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

This is report 1 of 10 for complaint (b)(4).

• Brand Name: 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 6401611
• MDR Text Key: 69856758
• Report Number: 2520274-2017-10854
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.016.034S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• 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
• Treatment: 03.010.064, 8.0MM/3.2MM DRILL SLEEVE 200MM, QTY 1; 03.019.006, INSERT HANDLE MULTILOC HUM NAIL, QTY 1; 03.019.007, CON SCREW/CAN MULTILOC HUM NAIL, QTY 1; 03.019.008, AIM ARM/LAT/MULTI LOCPRO HUM NL, QTY 1
• Patient Age: 50 YR