MAUDE Adverse Event Report: STRYKER GMBH COMBINATION REAMER ASSEMBLY OMEGA PLUS TI; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 704105

Device Problem Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "pierced the head with a reamer probably because the stopper was not firmly fixed.".

Event Description

As reported: "pierced the head with a reamer probably because the stopper was not firmly fixed.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was returned and is working as intended.The device inspection revealed the following : the visual inspection of the device shows that overall it is in good condition.Some scratches can be noticed on the reamer drill shaft, most probably due to an improper insertion of the barrel reamer part.The functional inspection shows that the tightening of the device can be done properly, in such a way that the tightening bolt does not move.The reported event was most probably due to an improper tightening of the device.This issue can be attributed to the user, since the bolt could be tightened properly.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: COMBINATION REAMER ASSEMBLY OMEGA PLUS TI
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10631865
• MDR Text Key: 209963611
• Report Number: 0008031020-2020-02290
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 704105
• Device Lot Number: Y59192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR