MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR 2 1.5MM & 2.0MM CORTEX SCREWS; EXTRACTOR

Catalog Number	309.51
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) reports an event as follows: it was reported that during a femur procedure on an unknown date, the extraction screw broke.Femur nail and hip screws has already been implanted.Procedure was completed successfully with a surgical delay of fifteen (15) minutes.Patient status is unknown.This report is for a conical extraction screw for 1.5mm & 2.0mm cortex screws.This is report 3 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6.The visual inspection of the returned extraction screw has shown that a piece of the tip section is broken off.The broken off piece was not returned for investigation.The instrument is all in all in used condition and there are clearly wear marks and scratches on the tip visible.Due to the strongly damages the relevant dimension could not be measured.However the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The received condition of the extraction screw is concordant with the complaint description and the complaint condition is confirmed.This lot was manufactured in february 2011 according to the specification.Based on that and the condition of the item a product related issue can be excluded.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production criteria¿s.Since the instrument is now more than 9 years old and due to the visible wear marks and damages on the tip section we have to assume that a mechanical overload situation has led to the breakage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot.Null,part: 309.510.Lot: 2685922.Manufacturing site: bettlach.Release to warehouse date: 16.Feb.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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.G5: device is not distributed in the united states but is similar to device marketed in the usa.H3, h6: the device was received, the investigation is in progress, 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.
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.Complaint is confirmed as we are able to confirm complaint description (broken) based on the received pictures.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 (information or/and material), 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 1.5MM & 2.0MM CORTEX SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9554065
• Report Number: 8030965-2020-00062
• Device Sequence Number: 13562482
• Product Code: HWB
• UDI-Device Identifier: 07611819018433
• UDI-Public: (01)07611819018433
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2019

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: 309.51
• Device Lot Number: 2685922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 02/11/2020; 03/04/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/28/2020; 03/02/2020; 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1