MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE GAMMA3 DISTAL TARGETING RIGHT, STATIC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-5350
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "during the calibration of the distal aiming device in a gamma3 operation, it was found intraoperatively that the tolerance deviates in the longitudinal axis, but that this cannot be set via the aiming device.The deviation was estimated to be 1mm so that the drill could not pass.Stryker employee checked all aiming bars in the clinic immediately after the event was announced.It was found that the deviation can always be enforced in different combinations, since the tolerance of the pin in the adjusting device in particular allows a slight rotation.In extreme cases, this leads to the deviation described above.The distal locking had to be done manually according to the standard method surgical delay of 10 minutes not longer.No other consequences reported.".
Additional Manufacturer Narrative
Although no product was returned, the reported event was confirmed based on the provided image.It was found that the tolerance of the pin in the adjusting device, combined with the interaction with the target device, allows a slight rotation potentially resulting in reduced targeting accuracy in the longitudinal direction.Impaired distal targeting accuracy is known and accepted in the rmf (risk management file).If determined during mandatory functional check prior to surgery the attached adjusting device can easily be re-adjusted manually.Generally, distal locking with standard free-hand-technique is always an option.The item was not returned.According to the initial reporter; the item is in use because it is still functional.In case other essential information becomes available we reserve the right to reopen the case for investigation and to assess a new root cause.
Event or Problem Description
As reported: "during the calibration of the distal aiming device in a gamma3 operation, it was found intraoperatively that the tolerance deviates in the longitudinal axis, but that this cannot be set via the aiming device.The deviation was estimated to be 1mm so that the drill could not pass.Stryker employee [.] checked all aiming bars in the clinic immediately after the event was announced.It was found that the deviation can always be enforced in different combinations, since the tolerance of the pin in the adjusting device in particular allows a slight rotation.In extreme cases, this leads to the deviation described above.The distal locking had to be done manually according to the standard method.Surgical delay of 10 minutes not longer.No other consequences reported.".

• Brand Name: ADJUSTING DEVICE GAMMA3 DISTAL TARGETING RIGHT, STATIC
• 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: 10766504
• Report Number: 0009610622-2020-00621
• Device Sequence Number: 3185075
• Product Code: LXH
• UDI-Device Identifier: 04546540520340
• UDI-Public: 04546540520340
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 1320-5350
• Device Catalogue Number: 13205350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1