MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HELICAL BLADE COUPLING SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	357.377
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part 357.377, lot 7681974: release to warehouse date: october 22, 2014.Supplier: (b)(4).No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) reports an event as follows: it was reported during a procedure while the helical blade was being impacted, the end of the coupling screw being used broke off, and hit the floor.The helical blade was still managed to be put in position.A wrench was used to detach the coupling screw from the blade.The procedure was successfully completed with no medical intervention needed.Concomitant device reported: helical blade (part unknown, lot unknown, quantity 1); impaction instrument (part unknown, lot unknown, quantity 1).This report is for a helical blade coupling screw.This is report 1 of 1 for (b)(4).

• Brand Name: HELICAL BLADE COUPLING SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10836835
• Report Number: 8030965-2020-08926
• Device Sequence Number: 3500928
• Product Code: LXH
• UDI-Device Identifier: 07611819737594
• UDI-Public: (01)07611819737594
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 357.377
• Device Lot Number: 7681974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1