MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; APPARATUS, AUTOTRANSFUSION

Catalog Number UNK_IPR

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/17/2018

Event Type  Injury  

Event Description

The user facility reported the patient went for a follow up visit to their surgeon and an x-ray showed that the tip of the drain was still in the patient's knee.A revision surgeon was required to remove 6 eyelets of the drain out of the patient's knee.There was no delay and no further medical intervention required.

Event Description

The user facility reported the patient went for a follow up visit to their surgeon and an x-ray showed that the tip of the drain was still in the patient's knee.A revision surgeon was required to remove 6 eyelets of the drain out of the patient's knee.There was no delay and no further medical intervention required.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7306348
• MDR Text Key: 101272615
• Report Number: 0001811755-2018-00468
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 4546540867551
• UDI-Public: (01)4546540867551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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