MAUDE Adverse Event Report: SYNTHES (USA) 6.5MM CANCELLOUS BONE SCREW 32MM THREAD/60MM; APPLIANCE,FIXATION,NAIL

Catalog Number 217.060

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

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

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.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.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 a left total hip revision on (b)(6) 2017, a screw tip broke.The surgeon was attempting to implant the screw with an unknown bone graft.The screw tip had broken in the pelvis while implanting it under power.The surgeon tried to remove the entire screw but was unsuccessful.Threads of the screw tip were left in the bone.The surgeon thought it was better to leave it in place.The remainder of the screw was removed easily.Procedure was completed successfully without delay.The patient¿s postsurgical outcome is unknown.The patient was initially implanted with unknown competitor¿s devices on an unknown date.Concomitant devices reported: unknown power instrument (part # unknown, lot # unknown, quantity # unknown), unknown bone graft (part # unknown, lot # unknown, quantity # unknown), unknown competitor¿s devices (part # unknown, lot # unknown, quantity # unknown).This report is 1 of 1 for (b)(4).

• Brand Name: 6.5MM CANCELLOUS BONE SCREW 32MM THREAD/60MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• 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: 6382794
• MDR Text Key: 69207141
• Report Number: 2520274-2017-10759
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974537
• 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
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217.060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• 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: UNKNOWN BONE GRAFT, QTY UNKNOWN; UNKNOWN COMPETITOR¿S IMPLANTS, QTY UNKNOWN; UNKNOWN POWER INSTRUMENT, QTY UNKNOWN
• Patient Age: 24 YR
• Patient Weight: 68