MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM

Catalog Number	03.019.020
Medical Device Problem Codes	Break (1069); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for proximal humerus fracture.During the surgery, the surgeon had a difficulty inserting the endcap.The surgeon removed the endcap and when the nurse wiped off the blood on the endcap with the gauze, an unknown small metallic fragment stuck in nurse¿s hand.The surgeon stopped using the endcap and screwdriver because it is possible that they had some problem and they became contaminated.The surgeon closed the incision without the endcap insertion and the surgery was completed within thirty (30) minutes delay.The nurse was checked by a blood test.Patient outcome is reported as stable.No further information is available.Concomitant device reported: casquillo-cierre multiloc p/hn/phn multi (part # 04.019.002s, lot # 50p4537, quantity 1).This report is for one (1) stardrive screwdriver t25 w/ coupling for 03.019.019/330mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10962174
• Report Number: 8030965-2020-09484
• Device Sequence Number: 641618
• Product Code: HXX
• UDI-Device Identifier: 07611819427204
• UDI-Public: (01)07611819427204
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.019.020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1