MAUDE Adverse Event Report: SYNTHES MONUMENT DHS®/DCS® GUIDE SHAFT WITH FLATS

Catalog Number	338.23
Medical Device Problem Codes	Bent (1059); Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.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 monument.Date of manufacture: (b)(6) 2013.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 one (1) dynamic hip and condylar screw system (dhs®/dcs®) guide shaft with flats and one (1) dhs®/dcs® coupling screw are bent and broken in two (2) pieces.The issue was discovered on (b)(6) 2017 at sterile processing.There was no patient or procedural involvement.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product investigation was performed.Part # 338.23 lot number # 7147074, dhs/dcs guide shaft was returned and reported to have become bent or broken.This condition is confirmed; there is a noticeable kink and bend in the device approximately twenty six millimeters from the distal end of the device.The device is not broken into separate pieces.This prevents the easy passage of the coupling screw through the cannula of the guide shaft.The device was manufactured in 1/2013 and is over four years old.The balance of the returned device is in fairly worn condition with markings and signs of wear along its length.A visual inspection, dhr review, and drawing review were performed as part of this investigation.A drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.This complaint condition was likely caused by over four years of consistent use and the application of excessive force on the product; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, dhr review, and drawing review were performed as part of this investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DHS®/DCS® GUIDE SHAFT WITH FLATS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6327842
• Report Number: 1719045-2017-10098
• Device Sequence Number: 1610125
• Product Code: FZX
• UDI-Device Identifier: 10886982193278
• UDI-Public: (01)10886982193278(10)7147074
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/19/2017

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: 338.23
• Device Lot Number: 7147074
• 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: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1