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

Model Number	6704-0-520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During a primary surgery, 2 separate dall miles cables with different lot codes broke during surgery.Surgical delay 1min, surgery completed successfully.Photos and device not available.No further information available due to hospital policy.
Additional Manufacturer Narrative
Updated the lot number, manufacturing and expiration date.Reported event: an event regarding crack/fracture involving a dall miles cables was reported.The event was not confirmed.Method & results: device evaluation and results: not performed because product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been no other events for the reported lot.Conclusion: it was reported that the patient had a surgical delay due to crack/fracture involving a dall miles cables.The exact cause of the event could not be determined because no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
During a primary surgery, 2 separate dall miles cables with different lot codes broke during surgery.Surgical delay 1min, surgery completed successfully.Photos and device not available.No further information available due to hospital policy.

• Brand Name: D-M 2.0MM BEADED CABLE SET VIT
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9973186
• Report Number: 0002249697-2020-00765
• Device Sequence Number: 665691
• Product Code: JDQ
• UDI-Device Identifier: 07613327036466
• UDI-Public: 07613327036466
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/26/2020

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 Expiration Date: 07/31/2024
• Device Model Number: 6704-0-520
• Device Catalogue Number: 6704-0-520
• Device Lot Number: 72984804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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: 70 YR