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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/24/2021
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11797303
• Report Number: 8030965-2021-03516
• Device Sequence Number: 3869568
• Product Code: HWE
• UDI-Device Identifier: 07611819408333
• UDI-Public: 07611819408333
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 532.103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention