MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4; EXTRACTOR

Catalog Number	309.520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 a screw got damage during surgery.There was a 30 minutes delay to the surgery.The fragments were removed.The procedure was successfully completed.This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
Event or Problem Description
The extraction screw was used to remove broken screws.
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: 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.Investigation site: cq zuchwil.Selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the received extraction screw shows that almost entire length of the threaded tip section has broken off.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Furthermore the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.Drawing/specification review: the used material was stainless steel 1.4112 as required and the measured hardness was within the specification.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the provided information we are not able to determine the exact cause of this complaint.We only can assume that exceeding applied mechanical overload during the loosening of a blocked screw caused the breakage of the threads.Therefore, we can confirm the visible damages are not from any manufacturing non-conformity.Please take notice on page 19 in surgical technique guide, version 036.000.918: during insertion ensure that enough axial pressure is exerted and retain the axis.Only use sharp-edged extraction screws (recommendation: one extraction).Do not use extraction screws with power tools.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 309.520, lot: 3l79040, manufacturing site: bettlach, release to warehouse date: apr 10, 2019.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.

• Brand Name: EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9354316
• Report Number: 8030965-2019-70466
• Device Sequence Number: 19498112
• Product Code: HWB
• UDI-Device Identifier: 07611819018440
• UDI-Public: (01)07611819018440
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309.520
• Device Lot Number: 3L79040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 01/09/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/07/2020; 01/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention