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

Catalog Number	03.900.042
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records 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 synthes reports an event in (b)(6) as follows: it was reported that on unknown date, during decontamination, a screwdriver shaft was found to be worn out and it cannot be used.There was no surgical procedure nor patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The complained screwdriver shows that the tip of the instrument is badly twisted in the direction of screw removal.Because of the damages, the complaint relevant dimensions cannot be checked to print specifications anymore.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 is most probably the reason for the deformation of the tip.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: l691943, manufacturing site: (b)(4), release to warehouse date: 26.February 2018.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.

• 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: 8445953
• Report Number: 8030965-2019-62182
• Device Sequence Number: 2839497
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: L691943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1