MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CLOSED TUBE CLIP GAMMA3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that : "during the installation of a nail gamma3 by [surgeon], a ruptured instrument set occurred during the locking of the cephalic screw; resulting in the loss of a part of the device, which came in the soft parts of the patient's hip." the customer replied: "the event occurred during the intervention, when the screw was locked.The procedure may have been completed, but additional manipulation was required when the unsuccessful attempt was made to retrieve the piece of the device that was lost from the patient.There were no clinical consequences for the patient at this time.".
Event or Problem Description
The customer reported that : "during the installation of a nail gamma3 by [surgeon], a ruptured instrument set occurred during the locking of the cephalic screw; resulting in the loss of a part of the device, which came in the soft parts of the patient's hip." the customer replied : "the event occurred during the intervention, when the screw was locked.The procedure may have been completed, but additional manipulation was required when the unsuccessful attempt was made to retrieve the piece of the device that was lost from the patient.There were no clinical consequences for the patient at this time.".
Additional Manufacturer Narrative
Correction: refer to d9/h3 device availability & d section - gtin.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the device must be available in order to determine the exact root cause.However, some of the possible causes could be, but not limited to: high forces developed due to intense usage during insertion of set screw, residual stress developed in the device due to repeated cycles of reprocessing etc.The ifu clearly instructs that: ¿¿ changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.[¿] stryker trauma & extremities typically does not specify the maximum number of uses appropriate for reusable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.¿ if any further information is provided, the complaint report will be updated.

• Brand Name: CLOSED TUBE CLIP GAMMA3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10299946
• Report Number: 0009610622-2020-00331
• Device Sequence Number: 13619864
• Product Code: LXH
• UDI-Device Identifier: 04546540396860
• UDI-Public: 04546540396860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1320-3010
• Device Catalogue Number: 13200125
• Device Lot Number: K0B28BD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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