MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sedation (2368)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the drill bit did not enter in nail.Proximal part loosened at the level of the connection of the nail.It was very difficult to remove the nail but no excessive force has been used and could be removed and replaced by another nail.The surgeon didn¿t ream the humerus.He put a multiloc nail with a diameter 8.5mm.It was not so easy to put the nail inside the humerus.He rotated the nail to align it with the lateral epicondyle.When he began to drill in the multiloc hole, it was impossible.The insertion handle has destroyed the proximal part of the nail; the proximal part of the nail is damaged, the nail is not broken.The removal of the nail was very difficult because of the grip of the nail in the distal part of the humerus.At the end, he put a multiloc nail with a diameter 7 mm.It was reported there was a fifteen minute delay in the procedure.This report is for an unknown drill bit.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

This report is for an unknown drill bit/unknown lot.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4512852
• MDR Text Key: 15906994
• Report Number: 2520274-2015-10932
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention