MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T25 STARDRIVE SCRWDRVR SHAFT 100MM; SCREWDRIVERS

Catalog Number	03.900.042
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a screwdriver shaft was found badly worn during decontamination.There was no patient or procedure involvement.This report is for one (1) t25 stardrive screwdriver shaft 100mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Visual inspection: the complained screwdriver shows that the tip of instrument is badly worn and slightly twisted in the direction of screw removal.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: 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.Lot 9536825 was manufactured in august 2015 and all parts were according to our specifications.Failure in material or production could not be detected.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information we are not able to determine the exact cause of this complaint.The damage at the tip indicates that a mechanical overloading situation during screw removal or simply regular wear is most probably the reason for the deformation of the tip.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.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 history lot part: 03.900.042 lot: 9536825 manufacturing site: (b)(4) release to warehouse date: 24.August 2015 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.
Additional Manufacturer Narrative
Updated additional information provided for reporting.Reporters state: (b)(6).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
On 04/08/2019 update: although the surgery was held in (b)(6) hospital, the device was send to (b)(6) for decontamination.It was reported that during the cleaning procedure, the device was badly worn.

• Brand Name: T25 STARDRIVE SCRWDRVR SHAFT 100MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8382889
• Report Number: 8030965-2019-61658
• Device Sequence Number: 19340278
• Product Code: HXX
• UDI-Device Identifier: 07611819791022
• UDI-Public: (01)07611819791022
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 03/12/2019

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: 03.900.042
• Device Lot Number: 9536825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 04/08/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/04/2019; 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1