MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; ARTHROSCOPE

Catalog Number UNK_IPR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2011

Event Type  Injury  

Manufacturer Narrative

Product not being returned.

Event Description

It was reported that a metal piece of the device broke off during a discectomy procedure in 2011.The metal was confirmed to be in the patient's neck after the patient underwent mri testing in 2014 due to unrelated injuries from an auto accident.It was further reported that the patient was advised to temporarily delay the surgical removal of the metal until the disc deteriorates more.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6015290
• MDR Text Key: 56914065
• Report Number: 0001811755-2016-02543
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_IPR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/10/2016
• 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): Required Intervention