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

Catalog Number	309.510
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.A device history record review has been requested.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 on (b)(6) 2018, a conical extraction screw was damaged during removal of a cannulated screw.While the doctor was using the conical extraction screw, the material lost its thread.The doctor had already tried to remove the screw in another procedure, but was not able to do so.It is unknown if there was surgical delay.Patient status and procedure outcome are unknown.Concomitant devices: cannulated screw (product: unknown, lot: unknown, quantity: 1) this report is for a conical extraction screw for 1.5mm & 2.0mm cortex screws.This is report 1 of 1 for (b)(4) and captures the intraoperative event.The cause of the revision surgery, the patient¿s discomfort, is captured under (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.Visual inspection: the photo showing the conical extraction screw (part #309.510, lot # l000923.1) was received at us cq.The photo shows the tip of the conical extraction screw stripped.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as the relevant part was not returned.Document/specification review: the relevant drawing(s) was reviewed; a dhr review could not be performed as the lot number and part number combination do not match.Conclusion: the complaint condition is confirmed as the photo with the conical extraction screw (part #309.510, lot # l000923.1) was received showing the tip of the screw stripped.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 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: 8255202
• Report Number: 8030965-2019-59986
• Device Sequence Number: 2154123
• Product Code: HWB
• UDI-Device Identifier: 10886982185815
• UDI-Public: (01)10886982185815
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/26/2018

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: 309.510
• Device Lot Number: L000923.1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1