MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D-M 2.0MM BEADED CABLE SET VIT; BONE FIXATION CERCLAGE.

Catalog Number	6704-0-520
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Long gamma was treated for trochanter fracture.Use dall miles with beads for reduction.Although it was reduced with a reduction forceps, dissection of the bone fragment was a little big.Wound a cable and applied a tension again with a tensioner, but the dissection did not disappear.After adding more tension, the cable was broken.Additional information confirmed; the primary surgery were not stryker products, the fracture occurred and a dall miles cable was chosen to fix.

• Brand Name: D-M 2.0MM BEADED CABLE SET VIT
• Common Device Name: BONE FIXATION CERCLAGE.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7703737
• Report Number: 0002249697-2018-02232
• Device Sequence Number: 732023
• Product Code: JDQ
• UDI-Device Identifier: 07613327036466
• UDI-Public: 07613327036466
• Combination Product (Y/N): N
• PMA/510(K) Number: K953818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: 6704-0-520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43