MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT,DRILL

Model Number 03.010.100

Device Problem Device-Device Incompatibility (2919)

Patient Problem Blood Loss (2597)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, open reduction internal fixation surgery was performed with multiloc humeral nail and the drill bit in question.After fixing the proximal area using the aiming arm, the surgeon drilled the distal hole with radiolucent drive and the drill bit.The drilling was done from a little more medial side.During drilling, the drill bit entangled a blood vessel and the vessel was damaged.The surgeon stopped bleeding and fixed the distal area.He inserted the end cap subsequently.After that, the blood vessel was identified as brachial artery, which was considered to be a branch (not main one) by its pulse and blood flow.The surgery was delayed by 120 minutes.The alert date is (b)(6) 2019 (jst).No further information is available.Concomitant devices reported: unknown guides/sleeves/aiming: aiming arm (part# unknown, lot# unknown, quantity# unknown) hn multiloc ø7 dcho can l180 tan (part# 04.016.180s, lot# unknown, quantity# 1) unk - radiolucent drive (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 3.2mm three-fluted radiolucent drill bit/needle point/145mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8836700
• MDR Text Key: 152500306
• Report Number: 2939274-2019-59421
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982067661
• UDI-Public: (01)10886982067661
• 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
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.100
• Device Catalogue Number: 03.010.100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HN MULTILOC Ø7 DCHO CAN L180 TAN; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - RADIOLUCENT DRIVE; HN MULTILOC Ø7 DCHO CAN L180 TAN; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - RADIOLUCENT DRIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR