MAUDE Adverse Event Report: SYNTHES GMBH 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED; GUIDE

Catalog Number	03.130.225
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part 03.130.225, lot 2l99995: manufacturing site: (b)(4).Release to warehouse date: april 29, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: the visual inspection of the received device showed that the 1.1 mm drill sleeve component was bent and red color epoxy marking was missing on one side.Additionally, scratches and nicks were observed on the device.No other visual damages were observed on the device.The dimensional inspection was performed near the bent location; the dimensions were conforming.The drawings reflecting the current and manufactured revisions were reviewed.No design issues or discrepancies were identified.The complaint was confirmed for the received device as a component in the device was bent.While no definitive root cause could be determined based on the provided information, it is possible that the device was encountered unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
The visual inspection of the received device showed that the 1.1 mm drill sleeve component was bent and red color epoxy marking was missing on one side.Additionally, scratches and nicks were observed on the device.No other visual damages were observed on the device.This report is for a drill sleeve.This is report 4 of 4 for (b)(4).

• Brand Name: 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11946918
• Report Number: 8030965-2021-04622
• Device Sequence Number: 16408682
• Product Code: FZX
• UDI-Device Identifier: 07611819690677
• UDI-Public: (01)07611819690677
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 03.130.225
• Device Lot Number: 2L99995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/07/2021
• 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: DRILL BIT Ø1.1 L56/39 F/CORE HOLE; DRILL BIT Ø1.1 L56/39 F/CORE HOLE; DRILL BIT Ø1.1 L70/39 F/CORE HOLE; SCRDRIVER SHAFT 1.3/1.5 T4 SELF-HOLDING