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

Model Number	2351-0030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
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 stryker sales representative reported that during the case, the screw came out of the t2 alpha guide wire handle.The silver bolt came out into the incision.The surgeon was able to locate the item but this resulted in a surgical delay.The surgeon was not using excessive force.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection revealed a loosened, not returned pin which drill hole, as the counterpart, showed traces of intended press-fit.Thus, a dimensional inspection could not be performed.A second pin was in place which ensured function of the handle.Hardness tests of remaining units revealed no deficiency.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.Based on investigation an exact root cause could not be determined.Upon request reported delay was cited having been probably 3-4 minutes for searching and removal of the disassembled pin which is within expected time frame.A non-conformity report had been opened in order to further investigate and address this issue for further details.
Event or Problem Description
The stryker sales representative reported that during the case, the screw came out of the t2 alpha guide wire handle.The silver bolt came out into the incision.The surgeon was able to locate the item but this resulted in a surgical delay.The surgeon was not using excessive force.

• 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; DE D-24232
• MDR Report Key: 9511482
• Report Number: 0009610622-2019-00976
• Device Sequence Number: 19411625
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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 Model Number: 2351-0030
• Device Catalogue Number: 23510030
• Device Lot Number: KME911857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1