MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CROSS PINNED HEX SCREWDRIVER SHAFT/QC; SCREWDRIVERS

Catalog Number	03.614.039
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a procedure on (b)(6) 2020, to extend the fusion from l4 to t3 and to remove the synapse and use k2ms pedicle screws as the patient had grown a thoracic lumbar system.To remove the synapse pedicle screws surgeon used cross pinned hex screwdriver shafts.While removing the screws, the head of the one of the screw broke off, so the surgeon used another cross pinned hex screwdriver shaft, but then the shaft of the screw sheared in the pedicle and the shaft of the another screw sheared just under the head of the screw.Cross pinned hex screwdriver shafts didn¿t fit the head of the screws perfectly.When being used to remove the screws they can strip as the head of the screws are star drives and not hexagonal.Surgeon had to change the surgical plan as the broken shafts were difficult to remove from the pedicles.Hooks had to be used at the bottom of the construct which added at least thirty (30) minutes to the operation.The correction achieved , but chances of long term results possibly reduced due to hooks.The broken screw shafts could not be removed and remained in the patient's pedicles.The synapse was used off label and bone mass had to be removed before the screws were attempted to be removed initially before they broke due to the fact they had been in the patient for approx 5 years.Patient's outcome is reported as successfully recovering.Concomitant device reported: cross pinned hex screwdriver shaft (part # 03.614.039, lot # unknown, quantity 1), unk - mono/polyaxial screws: synapse (part # unknown, lot # unknown, quantity 2).This report is for one (1) cross pinned hex screwdriver shaft.This is report 1 of 4 for complaint (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.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Extended pcf due to covid-19 and the sc can not access the hospital 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: CROSS PINNED HEX SCREWDRIVER SHAFT/QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9856010
• Report Number: 8030965-2020-02114
• Device Sequence Number: 11355968
• Product Code: HXX
• UDI-Device Identifier: 07611819310612
• UDI-Public: (01)07611819310612
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/28/2020

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: 03.614.039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; UNK - MONO/POLYAXIAL SCREWS: SYNAPSE; UNK - MONO/POLYAXIAL SCREWS: SYNAPSE
• Outcome Attributed to Adverse Event: Required Intervention