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

Catalog Number	03.610.602
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.Event date: unknown.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: mar 28, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 two (2) self-retaining screwdrivers for quick lock screws where found broken during routine inspection of equipment.It was noted the prongs at the end of the screw drivers were broken off.There was no patient or procedural involvement.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that two (2) self-retaining screwdrivers for quick lock screws broke during inspection of equipment.It was noted the prongs at the end of the screw drivers were broken off.There was no patient involvement and no procedure.This complaint involves two devices.Part# 03.610.602; lot# - 8837081.The returned screwdriver was confirmed to have one prong broken completely off.The three remaining prongs were found to be bent slightly outward and in the direction of screw insertion.The balance of the device is in good condition.Part# 03.610.602; lot# l177162.The returned screwdriver was confirmed to have one broken prong.Another prong was found to be severely bent inward and the remaining two prongs were slightly bent outward and in the direction of screw insertion.The balance of the device is in good condition.No definitive root cause was able to be determined.It was noted that the devices broke during inspection.The circumstances around the use and cleaning of the devices are unknown.It is likely that the devices experienced excessive torque during use which may have caused the prongs to weaken and be susceptible to breakage.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the devices are already broken.Device 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
Updated information on reported event: it was reported that two (2) self-retaining screwdrivers for quick lock screws broke during inspection of equipment.It was noted the prongs at the end of the screw drivers were broken off and that in addition to the broken prongs, the remaining prongs were found to be bent slightly outward and in the direction of the screw insertion.The balance of the device is in good condition.

• 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: 6303255
• Report Number: 3003875359-2017-10049
• Device Sequence Number: 10887720
• Product Code: HXX
• UDI-Device Identifier: 10705034713670
• UDI-Public: (01)10705034713670(10)8837081
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: 8837081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1