MAUDE Adverse Event Report: SYNTHES GMBH SM BATT DRIVE 14.4 VLT LITHIUM ION BATT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.103

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

Patient Problem Cardiac Perforation (2513)

Event Date 03/24/2021

Event Type  Death  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: k- wire device, chuck device, battery casing device, small battery drive device, (b)(6) 2021.The lot number was unknown; therefore, the device manufacture date is unknown.The manufacturing site name is unknown.The reporter¿s phone number and complete facility address were not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

This is report 4 of 4 for the same event: it was reported from (b)(6) that during a proximal humeral fracture surgery, while using a ¿nail (mdm product)¿ and the chuck device, it was discovered that at the time of insertion of the lateral fixation screw, while drilling the proximal part of the upper arm, the k-wire device (competitors¿ product) for temporary fixation interfered/had contact with the chuck, causing the k-wire to enter the body, and reaching the patient's heart.It was reported that the patient expired.The exact date of the patient¿s death was not reported.It was reported that the battery device was used together with the small battery drive device, battery casing device and the chuck device.It was not reported if there were any delays in the surgical procedure or if a spare device were available for use.There were no reports of any allegation of malfunction against the devices.There was patient involvement reported.Multiple attempts were made to obtain additional information regarding the event.The reporter was unable to provide any additional information regarding this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SM BATT DRIVE 14.4 VLT LITHIUM ION BATT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 11797303
• MDR Text Key: 249697133
• Report Number: 8030965-2021-03516
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819408333
• UDI-Public: 07611819408333
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 532.103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• 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): Death; Required Intervention