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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2018
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
The customer reported that a guidewire broke intra-operatively.The item broke outside the patient and nothing was left inside the patient.The customer further reported that a second guidewire wore through during the same case.The customer was using the rigid stryker guidewire in conjunction with a non-stryker reamer and the reamer broke.The stryker guidewire remains stuck inside the non-stryker reamer and will not be coming back to stryker for inspection.There were no adverse consequences arising form the use of the 2 stryker guidewires.There was a surgical delay but the length of the delay was unknown on intake.
Additional Manufacturer Narrative
The reported event that guide wire, ball-tipped, sterile t2 femur ø3x1000 mm was alleged of -a - instruments - guide wire - broken could be confirmed.According to the event description ¿the item broke outside the patient and nothing was left inside the patient.The device inspection revealed the following: at the area of the breakage line circumferential grooves could be verified.Furthermore, significant signs of overheating [limited to the area of the breakage line] could be verified as well.However, an exact root cause could not be determined but based on the above facts the reported event is not related to a deficiency of the device and in case of intended use such damage would not have occurred.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.
Event or Problem Description
The customer reported that a guidewire broke intra-operatively.The item broke outside the patient and nothing was left inside the patient.The customer further reported that a second guidewire wore through during the same case.The customer was using the rigid stryker guidewire in conjunction with a non-stryker reamer and the reamer broke.The stryker guidewire remains stuck inside the non-stryker reamer and will not be coming back to stryker for inspection.There were no adverse consequences arising form the use of the 2 stryker guidewires.There was a surgical delay but the length of the delay was unknown on intake.

• 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: 7744878
• Report Number: 0009610622-2018-00457
• Device Sequence Number: 1758026
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 12/03/2018

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: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 18060085S
• Device Lot Number: K097250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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