MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 03.010.000

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier, date of birth and weight are unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Facility phone number is unknown.G5 (510k): device is not distributed in the united states, but is similar to device marketed in the usa.Used to capture change in surgical plan: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a nail expert ablation procedure performed on (b)(6) 2018 some nonfunctional products were received from a loan kit.There was blunt screwdriver, insufficient screwing footprint, so the surgeon couldn't remove the nail and had to close the patient.Patient consequences reported as nail could not be removed and the patient had to go through an anesthesia for nothing.This report is for one (1) conical extraction screw for ti femoral and tibial nails.This is report 2 of 2 for complaint (b)(4).

Event Description

Update 04/26/2018: patient status / outcome : surgeon was to remove the nail,however, the female patient kept the nail and went through with the anesthesia.Surgery was not delayed due to the reported event.

Manufacturer Narrative

Updated additional event information provided.Device was used for treatment, not diagnosis.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Reporter name, and email address.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.

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.Product was not returned.Based on the received pictures this complaint is rated as confirmed.Because of the information which was made 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.Corrected information: retracting the surgical delay information reported on the previous follow-up medwatch.This information was reported inadvertently on the medwatch.Complainant device is not expected to be returned for manufacturer review/investigation.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 TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7343192
• MDR Text Key: 102577991
• Report Number: 8030965-2018-52123
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819160361
• UDI-Public: (01)07611819160361(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/19/2018; 04/26/2018; 05/17/2018
• Supplement Dates FDA Received: 04/13/2018; 04/30/2018; 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention