MAUDE Adverse Event Report: SYNTHES HAGENDORF SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC; SCREWDRIVERS

Catalog Number	03.620.064
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Date of device damage is not known.Device is an instrument and is not implanted/explanted.Hospital contact telephone: (b)(6).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing site: (b)(4).Manufacturing date: 30.July 2013.The manufacturing documents of both screwdrivers were reviewed and no complaint related issues were found.The visual inspection has shown that the tips of both screwdrivers are in a used condition.The first millimeter of both stardrive tips is stripped, it is assumed that this is the complained fault and therefore the complaint is confirmed for both screwdrivers.The relevant dimension of both devices cannot be verified anymore due to the damage.However, the damage itself is a clear indication that inappropriate handling did lead to this issue.As only the forefront of the stardrive is damaged does show that these screwdrivers were once not fully inserted into a screw recess and by this the force was not distributed onto the complete stardrive surface as designed, which did finally lead to a mechanical overload at the forefront of the stardrive.No product related issue could be detected.Dhr review, no findings.Chu evaluation, no findings.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 europe reports an event in the (b)(6) as follows: it was reported two (2) screwdriver shafts were reported to be worn and dull and were removed from service.No patient or surgery involvement.Evaluation of the devices revealed the tips are stripped.This report is for one (1) straight tip screwdriver shaft.This is report 1 of 2 for (b)(4).

• Brand Name: SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6670191
• Report Number: 3003875359-2017-10308
• Device Sequence Number: 19102623
• Product Code: HXX
• UDI-Device Identifier: 07611819941786
• UDI-Public: (01)07611819941786(10)8420298
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2017

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: 03.620.064
• Device Lot Number: 8420298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1