MAUDE Adverse Event Report: SYNTHES MONUMENT 1.0MM TI CABLE WITH CRIMP DOUBLE LEAD 470MM-STERILE; CERCLAGE FIXATION

Catalog Number 491.992.01S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device broke during the procedure; it was not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 Description

It is reported during an unknown spinal procedure at unknown levels, surgeon was attempting to tighten the spine cable when the cable broke.Broken cable and all fragments were retrieved from patient.Another cable was implanted and procedure was completed successfully with no delay and no harm to patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Part 491.992.01s, lot p210072: release to warehouse date: may 14, 2015.Expiration date: march 31, 2024.Manufacturing site is synthes (b)(4) and supplied by (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that 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.

• Brand Name: 1.0MM TI CABLE WITH CRIMP DOUBLE LEAD 470MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5311145
• MDR Text Key: 33894719
• Report Number: 1719045-2015-10833
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 491.992.01S
• Device Lot Number: P210072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 47