MAUDE Adverse Event Report: SYNTHES SELZACH 2.9MM/5.0MM DRILL-REAMER QC/145MM FOR 4.0MM ASLS

Catalog Number	03.025.027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	02/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Device history record: manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: 16 july 2014.Release to warehouse (b)(4): 21 july 2014.No nonconformances were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4): additional medical intervention was required; a vascular surgeon was required to repair the vessel.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 or Problem Description
It was reported that during a closed reduction intramedullary nailing surgery of a fractured humerus on (b)(6) 2017 the surgeon violated the brachial artery while using a drill/reamer from a synthes set.Upon distal locking of the nail, the surgeon damaged the artery with a 2.9mm/5.0mm drill-reamer for use with the 4.0mm angular stable locking screw system.Patient was experiencing a large quantity of blood loss.The surgeon was able to temporarily control blood loss with surgical instrumentation from the hospital instrument tray.Additional medical intervention was required; a vascular surgeon was required to repair the vessel.The surgeon completed the im nailing procedure prior to the repair of the blood vessel.The procedure was completed successfully.No surgical delay was reported.Patient status is stable.Concomitant devices: nail, unknown part/unknown lot, qty 1.This is report 1 of 1 for (b)(4).

• Brand Name: 2.9MM/5.0MM DRILL-REAMER QC/145MM FOR 4.0MM ASLS
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• MDR Report Key: 6373988
• Report Number: 3000270450-2017-10071
• Device Sequence Number: 10913329
• Product Code: HTO
• UDI-Device Identifier: 10886982069818
• UDI-Public: (01)10886982069818(10)U204660
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2017

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: 03.025.027
• Device Lot Number: U204660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2017
• Initial Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 QTY FOR UNKNOWN NAIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 86