MAUDE Adverse Event Report: INTEGRITY ORTHOPAEDICS INTEGRITY ORTHOPAEDICS; TENDON SEAM

Model Number	901003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 27 march 2026, integrity ortho became aware of a complaint associated with a rotator cuff repair procedure in which the integrity ortho tendon seam system instrument assembly and instruments from another manufacturer were used.During the procedure, the surgeon observed a small piece of material on the surface of the rotator cuff, described as approximately the size of a grain of sugar or salt and suspected to be metallic in composition.The material was removed intraoperatively using a surgical shaver and discarded, and the procedure continued.The identification and removal of this material constituted medical intervention to preclude potential impairment and therefore meets the definition of a serious injury; this is the basis for medical device reporting in this case.During the same procedure, resistance was reported during placement of one anchor (anchor 5).Following anchor delivery and punch retraction, the anchor did not remain seated in bone and was clipped and removed intraoperatively in accordance with the instructions for use, which address management of unseated anchors as a known intraoperative occurrence.This event did not result in patient injury, did not require medical intervention, and did not adversely impact the repair outcome.A subsequent anchor (anchor 6) was placed without resistance, and the surgeon completed the procedure successfully.
Additional Manufacturer Narrative
This report is submitted due to intraoperative identification & removal of a small piece of material from the rotator cuff, constituting medical intervention to preclude potential impairment & the sole basis for mdr.An unseated anchor also occurred; management is addressed in the ifu and did not result in injury or adverse outcome.Device evaluation found no fracture, separation, missing components, or retained material.Investigation is complete.Following the procedure, the instrument assembly was retrieved and returned for evaluation.Visual, functional, and magnified inspection of the punch, nub tube, and introducer shaft confirmed that no material was missing from any component.No fracture, cracking, material separation, or missing components were identified, including from the distal tip of the introducer shaft or the punch pin.The face of the introducer shaft showed no chipping or missing material from contact with bone.Two abnormalities were noted: the distal tip of the nub tube was bent, and the nub tube slot, which is intended to remain straight, was twisted, resulting in misalignment.A blemish was observed on the distal most section of the inner diameter of the introducer shaft.Under magnification, material appeared displaced and compressed along the interior rim; however, there was no objective evidence of material loss, shedding, or separation.Functional testing conducted demonstrated failure of the instrument assembly due to the bent nub tube retracting with each trigger squeeze, preventing the nub tube from maintaining the required extended length.The bent and twisted nub tube required increased force to actuate through the introducer shaft, consistent with the surgeon's report of resistance during anchor 5 deployment.The laser cut nub tube specification requires the nub tube to remain straight, and the observed deformation represents failure to meet this requirement after use.Additional information provided by the integrity ortho sales representative present during the procedure clarified that, prior to deployment of anchor 5, the instrument assembly was rotated to a more advantageous position while the nub tube remained extended into bone to facilitate anchor deployment.This action contradicts ifu precautions requiring maintenance of proper alignment during insertion and disengagement of the delivery instrument and specifically instructing not to rotate or twist the instrument once the punch is extended.This deviation from ifu precautions is considered the most likely cause of the observed bending and twisting of the nub tube and the resulting loss of alignment.Interaction between the deformed nub tube and the introducer shaft may have contributed to the displaced material observed on the interior distal tip; however, there is no evidence that material was released from the device.The metallic material removed from the patient was discarded and unavailable for analysis; therefore, its composition and source could not be confirmed.While the integrity ortho instrument assembly contains metallic components, comprehensive evaluation identified no missing material from any patient contacting component, and there is no objective evidence that any component fractured, separated, or was retained in the patient.Other surgical instruments were used during the procedure, including a non integrity arthroscopic burr during subacromial decompression performed earlier in the case, which represents a potential alternative source of the observed material.Post procedure imaging reportedly did not identify any pre existing implants or hardware that could account for the fragment.A review of complaint history over the past 12 months identified no prior complaints involving unknown material found in a patient.Previous complaints involving bent nub tubes did not allege foreign material and did not demonstrate missing material upon returned product evaluation.Manufacturing and device history record reviews identified no nonconformances, and there is no indication that the device failed to meet specifications prior to use.Based on the available information, the root cause of the material found in the patient could not be definitively determined due to the lack of the retrieved material for analysis.There is no objective evidence to indicate that the integrity ortho tendon seam system instrument assembly was the source of the reported material.The involvement of other surgical instruments prevents exclusion of alternative sources.The deformation of the nub tube and displaced material within the introducer shaft are most consistent with use outside ifu precautions.No corrective action is being taken, as this is the first occurrence, no adverse trends were identified, and no relationship between the device and the reported incident was established beyond the inability to definitively exclude involvement.

• Brand Name: INTEGRITY ORTHOPAEDICS
• Common Device Name: TENDON SEAM
• Manufacturer (Section D): INTEGRITY ORTHOPAEDICS; 5565 pioneer creek dr.; maple plain MN 55359
• Manufacturer (Section G): INTEGRITY ORTHOPAEDICS; 5565 pioneer creek dr.; maple plain MN 55359
• Manufacturer Contact: kevin maloney ; 5565 pioneer creek dr; maple plain, MN 55359
• MDR Report Key: 24933035
• Report Number: 3026368553-2026-00001
• Device Sequence Number: 16134371
• Product Code: LXH
• UDI-Device Identifier: 00860013905934
• UDI-Public: 00860013905934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2026
• Device Model Number: 901003
• Device Catalogue Number: 901003
• Device Lot Number: B2602125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: #11 BLADE; ARTHREX ARTHROSCOPIC BURR; ARTHREX ARTHROSCOPIC SHAVER; ARTHREX ARTHROSCOPIC SHOULDER TRAY; ARTHREX DISPOSABLE SCOPION NEEDLE; ARTHREX RADIO FREQUENCY WAND; ARTHREX SCOPE AND HIGH FLOW CANNULA SYSTEM; S&N 1.8MM QFIX KNOTLESS DRILL GUIDE, BIT & IMPLANT; SMITH & NEPHEW HEALICOIL KNOTLESS IMPLANT SYSTEM; STRYKER POWER SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White