MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 70 DEG UP; PASSER

Catalog Number CAT02590

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that the surgeon was using a slingshot 70 degree to help close the capsule during a hip arthroscopy.The slingshot extendable piece snapped and broke off into the joint which was unable to retrieved.The tip was identified via x-ray and tried to retrieve it, however couldn't get close enough to it to pull the tip out of the joint.There was 1.5 hours additional procedure time.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

• Brand Name: SLINGSHOT 70 DEG UP
• Type of Device: PASSER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19076336
• MDR Text Key: 339775260
• Report Number: 0002936485-2024-00307
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 07613252656616
• UDI-Public: 07613252656616
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CAT02590
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other