MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510030
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Surgeon was using the t2 alpha guide wire gripper, whilst using it a small screw fell out.There was a slight delay of 5 minutes in the procedure as the staff fetched another guide wire handle.Stryker rep reported that there was no impact to the patient.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation an exact root cause could not be determined but nothing was reported during pre-operative check, which is required per ifu.In case of any material integrity issues it would have been noticed during inspection steps performed.The device inspection revealed the following: we received a guide wire handle imn instruments for evaluation.Detailed visual inspection revealed a loosened pin, which shows traces of pushing out and one missing pin.Due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection of the returned pin, handle and clamping barrel revealed the required measurements within specification.Although the loosened pin could be confirmed, required measurements were within specification.Review of historical data revealed the current case as a single case.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
Surgeon was using the t2 alpha guide wire gripper, whilst using it a small screw fell out.There was a slight delay of 5 minutes in the procedure as the staff fetched another guide wire handle.Stryker rep reported that there was no impact to the patient.

• Brand Name: GUIDE WIRE HANDLE IMN INSTRUMENTS
• 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: 8732805
• Report Number: 0009610622-2019-00519
• Device Sequence Number: 14113183
• Product Code: LXH
• UDI-Device Identifier: 07613327361674
• UDI-Public: 07613327361674
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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 Catalogue Number: 23510030
• Device Lot Number: KME912621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1