MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0370
Medical Device Problem Codes	Separation Failure (2547); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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 customer reported that : "stryker tibia nail fixation sleeve stuck in the tibia nail holder (1806-1002 - n°kh171892) and in the nail: impossible to unscrew them and therefore to place the nail (1822-1034s - n°k03f75c) in the patient, therefore change the size of the nail and place a nail without an ancillary.In the end, there is no clinical impact for the patient.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received devices were not possible to disassemble although, a real root cause could not be determined but the alleged event is most likely caused due to an oblique insertion/cross threading/some debris inside the hole.The investigation of the parts involved indicates that it is likely that the observed issue of seizing of the nail holding screw is possible, if an unfavorable constellation of several dimensions (extreme value and specific direction) meet when assembling the devices.The device inspection revealed the following: visual inspection: we received the nail holding screw and the nail handle in an assembled condition for evaluation.All devices were received in a blocked mode.The thread of the nail holding screw could be identified as damaged.The first windings show shearing.Furthermore, the nail holding screw in question presents signs of damage at the head and a nonform fit inside the nail handle.Disassembling of devices was undertaken with a drill drift but to no avail.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible.The file will be closed in accordance to our procedures.In case substantive information will become available in future the file will be reviewed and reopened.
Event or Problem Description
The customer reported that : "stryker tibia nail fixation sleeve stuck in the tibia nail holder (1806-1002 - n°kh171892) and in the nail: impossible to unscrew them and therefore to place the nail (1822-1034s - n°k03f75c) in the patient, therefore change the size of the nail and place a nail without an ancillary.In the end, there is no clinical impact for the patient.".

• Brand Name: NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
• 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: 11841974
• Report Number: 0009610622-2021-00517
• Device Sequence Number: 3777792
• Product Code: LXH
• UDI-Device Identifier: 04546540196484
• UDI-Public: 04546540196484
• 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): 06/16/2021

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: 1806-0370
• Device Catalogue Number: 18060370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1