MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE

Catalog Number	03.607.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information not available for reporting.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.(b)(6).It was reported that the driver broke off intra-operatively during insertion.The screw had to be removed and replaced for insertion into a different location.A surgical delay of 60 minutes was reported.Device history records review was conducted.The report indicates that the: part no.: 03.607.001, lot no.: 8433722, manufacturing location: haegendorf, release to warehouse date: (b)(6) 2013.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 on an event in (b)(6) as follow: it was reported that on (b)(6) 2018, the surgery for the l3 fracture was performed by using the uss ii ilio-sacral system.The fixed area was l3/ ilium.When the screw was inserted to the left ilium, the tip of the screw driver shaft was broken.The screw was removed and re-inserted from a different place.The surgery was completed with a 60-minute-delay, and there was no adverse consequence (no nervous symptoms) to the patient.Complaint involves two (2) parts.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.Customer quality conducted an investigation of the returned device.The evaluation has shown that the tip of the screwdriver is broken off as complained.The fragment of the tip is stuck in the recess of the screw.The remainder of the double hexagon tip is strongly twisted in clockwise direction.The device is in a used condition, especially at the handle are different marks, like scratches and nicks, visible.Due to the damage at the tip the relevant dimensions cannot be verified anymore.Therefore the manufacturing documents were reviewed and no complaint related issues were found.There was no deviation regarding dimensions, the correct material (1.4034 stainless steel) was used and the hardness was between 620-640 hv10, which is within the specification 580 +80/0 hv10.The lot was manufactured in june 2013 with a lot size of 15 pieces and we are not aware of any other complaint for this article- and lot combination.These findings speak against a manufacturing related issue.As stated above, the remainder of the tip is strongly twisted in counterclockwise direction.This is a clear indication of a mechanical overload during the insertion of the also received 80mm long uss-ii-polyaxial cancellous screw.In this relation we would like to point out the uss ii ilio-sacral surgical technique, where following statement can be found: note: for cancellous bone screws with a length of 70 mm or longer, use the screwdriver shaft 03.607.002 attached to the uss ii polyaxial handle.The screwdriver shaft 03.607.002 is connected to the outer surfaces of the screw and does therefore withstand the higher torque that may be needed for the insertion of long screws.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 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: 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7308679
• Report Number: 8030965-2018-51623
• Device Sequence Number: 16514936
• Product Code: HXX
• UDI-Device Identifier: 07611819185371
• UDI-Public: (01)07611819185371(10)8433722
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.607.001
• Device Lot Number: 8433722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 04/16/2018; 05/02/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/16/2018; 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention