MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS; EXTRACTOR

Catalog Number	309.52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on an unknown date that during an unknown surgery, when removing the distal screws, it was broken.When trying to place it on the head of the screw to be removed and when activating the motor, the tip is split which cannot be recovered.It was unknown that the surgery was delayed or completed successfully.The patient outcome was unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 procedure was successfully completed after removing the material the patient had implanted.The removal screw that was broken was replaced with lfn nail material to finish removing the screw.There was no surgical consequence.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part number: 309.520, lot number: 5l83025, manufacturing site: bettlach, release to warehouse date: september 19, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10022254
• Report Number: 8030965-2020-03290
• Device Sequence Number: 3116371
• Product Code: HWB
• UDI-Device Identifier: 07611819018440
• UDI-Public: (01)07611819018440
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 309.52
• Device Lot Number: 5L83025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 06/17/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/22/2020; 06/29/2020
• 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: EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4; UNK - SCREWS: TRAUMA
• Patient Age: 26 YR
• Patient Weight: 87