MAUDE Adverse Event Report: SYNTHES HAGENDORF SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS; SCREWDRIVERS

Catalog Number	03.610.602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Event date: unknown when device malfunctioned.Implant and explant dates: 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.A device history record (dhr) review was performed for part # 03.610.602, lot # l244641: manufacturing location: (b)(4), manufacturing date: 15.Feb.2017: no non-conformance reports (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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that while the sales consultant was checking the set he discovered that the prongs at the tip of two screwdrivers were broken off.He also discovered that all the prongs at the end of one of the locking screwdrivers were deformed and would not fit in a screw, and that one of the prongs at the end of a drill guide had snapped off and was missing.There was no patient and surgical procedure involvement.This report is for one (1) self-retaining screwdriver for quick lock screws with broken prong tip.This is report 1 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
The device was received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: lot#, udi#: (b)(4).Device history records review was completed for part# 03.610.602, lot# l198313.Manufacturing location: (b)(4), manufacturing date: dec 20, 2016.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
This is report 1 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Customer quality (cq) engineering investigation: this complaint is confirmed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned devices are already either broken or malformed.Visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.Visual inspection: self-retaining screwdriver (p/n 03.610.602, lot#lot# l198313 and 9600901): one tooth out of four teeth for each of the self-retaining screwdriver was broken.The broken fragments were not returned with the complaint.The tip of the screwdriver with lot#9600901 showed lot of scratches on the tip region.The remaining teeth for both the screwdrivers were slightly bent outwards.The overall balance of the devices look in a good condition with some minor wear on rest of the device body.Dhr reviews: no ncrs were generated during production of all four above devices.Review of the device history record showed that there were no issues with the material, hardness and during the manufacturing of these products that would contribute to the complaint conditions.Drawing review: self-retaining screwdriver for quick lock screws (p/n 03.610.602, lot# l198313 and 9600901) expansion head screwdriver drawing and lower expansion sleeve drawing the width of all the remaining teeth of both the returned screwdrivers measured per drawing and found to be within specification in the range 1.20 -1.23 mm (spec: 1.2 mm +0.05/-0) and the outer diameter at the tip measured within spec at 4.33 mm for both the screwdrivers (spec: 4.38 mm +0/-0.05).Hence no drawing issues or discrepancies were noted.The designs are adequate for the intended use and did not contribute to this complaint condition.The broken tips of all the screwdrivers could be a result of application of excessive torque or applying torque when the device tip is not fully engaged.The observed deformed tip and/or outward bent tip teeth also support the above possibility.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: SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6919002
• Report Number: 3003875359-2017-10490
• Device Sequence Number: 10942054
• Product Code: HXX
• UDI-Device Identifier: 10705034713670
• UDI-Public: (01)10705034713670(10)L244641
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2017

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: 03.610.602
• Device Lot Number: L198313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 10/17/2017; 11/16/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/06/2017; 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1