MAUDE Adverse Event Report: STRYKER GMBH INTERMEDIATE NAIL, RIGHT D10X240MMX125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	82250240S
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted in the patient.
Event or Problem Description
As reported: "when drilling to insert a lateral stop screw into the distal dynamic hole, the drill hit into the posterior wall of the nail.Surgeon tried to correct the trajectory, but because of the hole, surgeon ended up not being able to insert the screw through the device, so he removed the device and managed to insert the screw freehand.".
Additional Manufacturer Narrative
As the nail was implanted and the surgical procedure successfully completed by free-hand-technique, this could be interpreted as an indication that no discrepancy with the nail used was suspected.Therefore, considered as concomitant and thus, this complaint is closed without further investigation.Finally, based on above and referring to the fact that nothing was reported at the time of pre-functional check performed, which is required before surgery, it could not be excluded that the case is rather related to sub-optimal intraoperative procedure.However, a check of both in combination was impossible as only counterpart was made available and further technical statement could not be given.Finally, as pointed out in the labelling ¿discard all damaged or mishandled implants¿.Complementary information about this event can be found under the main investigation for the targeter.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
As reported: "when drilling to insert a lateral stop screw into the distal dynamic hole, the drill hit into the posterior wall of the nail.Surgeon tried to correct the trajectory, but because of the hole, surgeon ended up not being able to insert the screw through the device, so he removed the device and managed to insert the screw freehand.".

• Brand Name: INTERMEDIATE NAIL, RIGHT D10X240MMX125DEG
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18437850
• Report Number: 0009610622-2024-00010
• Device Sequence Number: 20741334
• Product Code: HSB
• UDI-Device Identifier: 07613327593723
• UDI-Public: 07613327593723
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: 82250240S
• Device Lot Number: K1776E0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown