MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SPEEDLOCK SLEEVE GAMMA3® 180; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13201118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
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
The speed sleeve and targeting arm would not allow the lag screw sleeves to pass through to line up with the proximal lag screw hole in the nail.The speed sleeve was removed and the surgeon did what he could to make sure he had the proper alignment.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Event or Problem Description
The speed sleeve and targeting arm would not allow the lag screw sleeves to pass through to line up with the proximal lag screw hole in the nail.The speed sleeve was removed and the surgeon did what he could to make sure he had the proper alignment.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
Correction: sections d10, h3.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for instrument placement & drilling was confirmed by pre-operative check, it was concluded that the event was mainly based in the intra-operative procedure.Reasons for misalignment are various.Potential miss-targeting can also be caused by: - loosening of the nail holding bolt during insertion of the nail - repeated tightening of the nail holding screw prior to proximal targeting / drilling is recommended - undetected unintended loosening of the attachment knob (will lead to release of the drill sleeve) - wrong nail selection a review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• Brand Name: SPEEDLOCK SLEEVE GAMMA3® 180
• 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: 8804340
• Report Number: 0009610622-2019-00540
• Device Sequence Number: 11347197
• Product Code: LXH
• UDI-Device Identifier: 07613154893652
• UDI-Public: 07613154893652
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 09/10/2019

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: 13201118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1