MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG ASSY TITANIUM INTRALINE ANCHOR 5.5MM; SCREW, FIXATION, BONE

Catalog Number	3910-400-050
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the placement of a shoulder anchor, it broke, with half of the anchor remaining in the bone and the other half outside the bone, for no apparent reason.The department claims that the broken fragments remaining in the patient were removed.There were no clinical consequences for the patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: broke probable root cause: process -inserter, implant, manufactured out of specification application -excessive force torquing anchor or lateral force applied during insertion -not enough axial force during insertion -use of wrong tap - improperly prepared hole -bone to hard for anchor insertion -bone not hard enough to maintain screw purchase -no pilot hole prepared the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during the placement of a shoulder anchor, it broke, with half of the anchor remaining in the bone and the other half outside the bone, for no apparent reason.The department claims that the broken fragments remaining in the patient were removed.There were no clinical consequences for the patient.
Additional Manufacturer Narrative
The product has now been received.The investigation is as follows.Alleged failure: during the placement of a shoulder anchor, it broke, with half of the anchor remaining in the bone and the other half outside the bone, for no apparent reason.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) use of excessive force, 2) bone too hard for anchor insertion.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during the placement of a shoulder anchor, it broke, with half of the anchor remaining in the bone and the other half outside the bone, for no apparent reason.The department claims that the broken fragments remaining in the patient were removed.There were no clinical consequences for the patient.

• Brand Name: PKG ASSY TITANIUM INTRALINE ANCHOR 5.5MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22877009
• Report Number: 0002936485-2025-00719
• Device Sequence Number: 10424532
• Product Code: HWC
• UDI-Device Identifier: 07613154890088
• UDI-Public: 07613154890088
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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: 3910-400-050
• Device Lot Number: 25017AE2
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 11/03/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/18/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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