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

Catalog Number	338.23
Medical Device Problem Codes	Bent (1059); Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review, part # 338.23, synthes lot # 7948013, supplier lot # 7948013, release to warehouse date: 16 mar 2015, supplier: (b)(6).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which 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
It was reported that three devices malfunctioned during a hip fracture repair performed on (b)(6) 2017.The "t" portion of the dhs/dcs (dynamic hip screw/dynamic condylar screw) wrench was noted to be exhibiting undesired movement and appeared as though it were about to break off.The dhs/dcs guide shaft with flats was bent during the surgery and would not engage the lag screw as expected.The dhs/dcs coupling screw was also noted to be bent and would not go through the dhs/dcs guide shaft with flats to properly engage the lag screw.No further information was provided.This report is for one (1) dhs/dcs guide shaft with flats.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Returned to manufacturer.Subject device has been received and is currently in the evaluation process.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
Concomitant devices reported: lag screw (part number unknown, lot number unknown, quantity 1).
Additional Manufacturer Narrative
The returned device was found to be bent approximately 30mm from the distal end of the device.Additionally, the prongs were determined to be twisted and deformed.The device shows surface wear which does not impact functionality.The complaint of the bent device is confirmed.Replication is not applicable.The outer diameter of the device was measured to be 7.75mm which is within the specification of 7.8mm +0/-0.1 measured using mitutoyo caliper.The inner diameter of the device was measured to be 5.07mm which is within the specification of 5.1 +/- 0.1 measured using vermont gage pin.No definitive root cause could be determined.It is likely that excessive force led to the broken and bent conditions.There were no issues during the manufacture of the products 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.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: DDHS®/DCS® GUIDE SHAFT WITH FLATS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6998308
• Report Number: 1719045-2017-11134
• Device Sequence Number: 19206522
• Product Code: FZX
• UDI-Device Identifier: 10886982193278
• UDI-Public: (01)10886982193278(10)7948013
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2017

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: 7948013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/31/2017; 11/28/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/20/2017; 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR