MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.101

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: multi-humeral nail device, adaptor device, quick coupling device and radiolucent drive device.The manufacturing location is unknown.The device serial or lot number was unknown; therefore, udi: (b)(4).Device manufacture date is unknown.(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 4 of 4 for the same event.It was reported from (b)(6) that during an open reduction internal fixation (orif) surgical procedure for a humerus diaphysis fracture using the multi-humeral nail long (mhn long) device, it was observed that the small battery drive device stopped working while drilling the first distal hole.According to the report, the event occurred after a proximal hole was fixed.It was reported that the small battery drive device was in use with a radiolucent drive device, adaptor device and a quick coupling device.It was further reported that the small battery drive device kept running idle with a scratching sound.It was reported that the surgeon reassembled the unit again and tried drilling but could not complete the drilling as the same issue occurred.As a result, the surgeon created the prepared hole with a gimlet and then drilled by hand.It was reported that the same event occurred at the second hole but the surgeon completed drilling using the same manual way.It was reported that the surgeon took time to change the battery and tried the same way at the third hole.It was reported that although the small battery drive device was about to stop, the surgeon managed to complete the drilling.It was reported that there was a 30 minute delay in the surgical procedure and the surgery was completed successfully using the same device.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): N/I; n/i; n/i
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7404044
• MDR Text Key: 104616006
• Report Number: 8030965-2018-52836
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.101
• Date Manufacturer Received: 03/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1