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

Catalog Number	18060085S
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7546056
• Report Number: 0009610622-2018-00215
• Device Sequence Number: 2018458
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 18060085S
• Device Lot Number: K03C560
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other