MAUDE Adverse Event Report: STRYKER GMBH INTERMEDIATE TARGETING SLEEVE GAMMA4; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14202100
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: when targeting accuracy was checked prior to nail insertion, the drill did not pass through the distal hole of the nail and contacted the anterior of the nail.When the nail was replaced and checked again, the drill made contact with the anterior of the nail as well.So, the surgeon switched to using other systems.
Additional Manufacturer Narrative
Correction - please refer to d9/h3 - the product was returned for evaluation, h6 (device &method code).The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received targeting sleeve was visually inspected where device looked to be in good appearance, but a small fragment of the clamping lever was broken from the thinnest cross-section of the web.The broken surface indicates towards breakage in a brittle manner as indicated by smooth surface without any plastic deformation and the surface around the breakage portion showed irregular milling groove indicating towards mishandling of the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a combination of user and manufacturing related issue.The event was caused as the device fell which is also stated in the event description and confirmed during device inspection as well.Although, an nc was previously opened because of a recurring issue of breakage of the device and a capa was initiated which suggests that there are manufacturing errors, leading to the piece to be more fragile and lead to breakage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: when targeting accuracy was checked prior to nail insertion, the drill did not pass through the distal hole of the nail and contacted the anterior of the nail.When the nail was replaced and checked again, the drill made contact with the anterior of the nail as well.So, the surgeon switched to using other systems.Update 9/2/24 additional information indicates the drill was damaged by falling due to the inspector's negligence.

• Brand Name: INTERMEDIATE TARGETING SLEEVE GAMMA4
• 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: 19997393
• Report Number: 0009610622-2024-00796
• Device Sequence Number: 11869942
• Product Code: HSB
• UDI-Device Identifier: 07613327591477
• UDI-Public: 07613327591477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• 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): 11/19/2024

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: 14202100
• Device Lot Number: KP505119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown