MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 18060085S

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Theatre staff went to open a 1000 x 3mm guide wire when they noticed a brown dust contaminant with the outer packaging end cap.It looked like it could have been attributed to water damage and so a different wire was opened.

Manufacturer Narrative

The reported event that guide wire, ball-tipped, sterile t2 femur 3x1000 mm was alleged of packaging: residue outside sterile blister or pouch could not be confirmed, since the device was not received for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Furthermore, not enough information is available to confirm the reported case (like a photo).According to stock movement the device was already distributed in 2015 and no deviation was reported during incoming inspection at distribution site.It could not be excluded that the pollution occurred during storage at distribution site or at the user site itself, which is beyond the manufacturers control.In case the item and/or substantive information will become available in future the file will be reviewed and reopened.Device was not returned.

Event Description

Theatre staff went to open a 1000 x 3mm guide wire when they noticed a brown dust contaminant with the outer packaging end cap.It looked like it could have been attributed to water damage and so a different wire was opened.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7546056
• MDR Text Key: 109491293
• Report Number: 0009610622-2018-00215
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 18060085S
• Device Lot Number: K03C560
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other