MAUDE Adverse Event Report: STRYKER GMBH CABLEFIX XPRESS CARPOMETACARPAL FIXATION SYSTEM; ARTHROSCOPE

Catalog Number CM9000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Manufacturer Narrative

On october 14, 2016, (b)(4), a wholly owned subsidiary of stryker corporation (collectively ¿stryker¿), acquired substantially all of the assets of (b)(4) (¿restore¿) (the ¿transaction¿).This mdr is submitted by (b)(4) as a result of a retrospective lookback resulting from the transaction.The reported devices were manufactured and distributed by restore prior to the closing of the transaction.Stryker became legal manufacturer of this product on october 14, 2016 and has taken the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device is not available to stryker.

Event Description

K-wire that is used with the cannulated drill bit broke.Patient unharmed throughout procedure.Initial use of the device.

• Brand Name: CABLEFIX XPRESS CARPOMETACARPAL FIXATION SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6185587
• MDR Text Key: 63111250
• Report Number: 0008031020-2016-00626
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CM9000
• Device Lot Number: 120120.04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other