MAUDE Adverse Event Report: SYNTHES HAGENDORF DRILL/TAP AND SCREW GUIDE WITH POST

Catalog Number	03.613.001
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient involvement.It is unknown when event occurred.Device is an instrument and is not implanted/explanted.A review of the device history records has been completed.Manufacturing location: (b)(6) manufacturing date: (b)(6) 2005 no non-conformance records 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 subject device has been received and is currently in the evaluation process.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 a prong on the end of a drill/tap and screw guide was discovered bent in a set.This was found outside of the operating room and does not involve a patient or procedure.The age of the device is unknown but it has been in use for approximately 4 years.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis a product investigation was performed.It was reported that a prong on the end of a drill/tap and screw guide was discovered bent in a set.This was found outside of the operating room and does not involve a patient or procedure.The returned drill/tap and screw guide with post was found to have a slightly bent prong.Additionally the position pin was found to be bent.The remainder of the device is in good condition.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 device is already bent.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.No definitive root cause was able to be determined.The bent instrument is likely related to application of off axis forces.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL/TAP AND SCREW GUIDE WITH POST
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6194718
• Report Number: 3003875359-2016-10657
• Device Sequence Number: 10910002
• Product Code: FZX
• UDI-Device Identifier: 10705034714547
• UDI-Public: (01)10705034714547(10)1407390
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 11/30/2016

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: 03.613.001
• Device Lot Number: 1407390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1