MAUDE Adverse Event Report: STRYKER INSTRUMENTS-IRELAND UNKNOWN_INSTRUMENTS_PRODUCT; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number UNK_INS

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2019

Event Type  malfunction  

Event Description

It was reported that while removing the cannula from the patient, that the cement did not set and that a trail of hardened cement was left inside in the patient.No medical intervention or further adverse consequences were reported.

Manufacturer Narrative

Device evaluation: the device was returned, however, due to the hardened state of the cement, it was not able to be evaluated.

Event Description

It was reported that while removing the cannula from the patient, that the cement did not set and that a trail of hardened cement was left inside in the patient.No medical intervention or further adverse consequences were reported.

Event Description

It was reported that while removing the cannula from the patient, that the cement did not set and that a trail of hardened cement was left inside in the patient.No medical intervention or further adverse consequences were reported.

Manufacturer Narrative

B1, malfunction only.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill MI NA ; EI NA
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8793735
• MDR Text Key: 151134378
• Report Number: 0001811755-2019-02285
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Device Lot Number: VHZ04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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