MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QUICKANCHOR ORTHOCORD; STAPLE, FIXATION, BONE

Catalog Number	222983
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11.Additional narrative: the product was not returned to depuy synthes for evaluation; however, photos were provided for evaluation.Visual inspection of the returned photos found that the device is shown in used condition.The needle was found broken at the proximal end, traces of being deformed and forced.Ductile fracture of metal can be observed.The overall complaint was confirmed as the observed condition of the gii qa+ o/c cp-2 each would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to a mechanical overload that was applied on the needle leading to a ductile fracture.Orif of the right pelvis procedure is contraindicated; as per instruction for use (ifu); contraindications: surgical procedures other than those listed in the indications section.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during an open reduction and internal fixation (orif) of the right pelvis surgery with a gii quickanchor orthocord, the needle fractured while attempting to pass the needle through the pelvic ischium bone.Retrieval of the fractured needle was required approximately 45 additional minutes of operating time, including the use of intraoperative x ray imaging.No patient consequence was noted.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: b5: was there any change in post op care to patient? no.Please confirm all the fragments were retrieved from patient? yes.This was confirmed through xray.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: corrected: b3.

• Brand Name: GII QUICKANCHOR ORTHOCORD
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24971125
• Report Number: 1221934-2026-01538
• Device Sequence Number: 10496791
• Product Code: JDR
• UDI-Device Identifier: 10886705008612
• UDI-Public: (01)10886705008612(10)10A7Q2(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 222983
• Device Lot Number: 10A7Q2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 04/24/2026; 04/29/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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 Age: 14 YR
• Patient Sex: Male