MAUDE Adverse Event Report: STRYKER CORPORATION CINCHLOCK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number CAT02462

Device Problems Break (1069); Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

Possible unintentional retained object.Procedural note: next, attention was turned to repairing the labrum.She had clear evidence of a recurrent acetabular labral tear and the remaining tissue quality was appropriate for revision primary repair.The 2 previously placed sutures were encountered during labral exposure and were removed.Approx 4 stryker/pivot cinchlock suture anchors were necessary to repair the labrum.High-tensile strength braided force fiber suture was passed through the labrum and secured to the acetabular rim using the suture anchors in a sequential fashion to complete the repair.The acetabular cartilage and joint surface was carefully monitored while drilling and placing the anchors to ensure this did not inadvertently breach subchondral bone.The labral repair was probed and noted to be well reduced and stable.Traction was then released.Intraop implant record shows 4 stryker cinchlock ss knotless cat02462 pivot medical anchor, lot #16060201 implanted.From surgeon: subject: styker cinchlock suture anchor device failure and peer review additions.I have commonly used the stryker cinchlock suture anchor for labral repair during hip arthroscopy.I recently noticed a retained metallic fragment on follow-up x-rays on two separate cases which generated the retrospective review of my practice and identified the total of four cases affected.This metallic fragment is a small wire that is contained within the anchor and acts to secure the anchor/suture when the insertion device is deployed.The wire is supposed to be retracted back into the delivery device and removed with the sheath.In all cases this small metallic fragment has remained stable on follow-up imaging and does not appear to be located between the femoral head and acetabular articular cartilage.The intra-operative arthroscopic images were reviewed for all patients and the metallic fragment was not visualized.In hindsight, you can see the metal fragment on the intra-operative c-arm views for all cases except (1 patient), however this would have been difficult to pick this up intra-operatively and failed to recognize this at the time of surgery.I suspect in these cases it is partially trapped within the anchor or stuck in the capsule.I do not think it will cause any additional harm or negatively impact the clinical outcome.As such, i recommended observation as i feel revision surgery in an effort to retrieve this metallic fragment would be potentially unsuccessful given the small size, likely cause additional harm and carry a greater risk of further injury/complications when compared to any potential realized benefit.Orthopaedic surgery update: the patient was called to check on her progress and to also disclose that she has a retained metal fragment identified retrospectively.Patient reports that her hip is doing very well and she is satisfied with her outcome.Unfortunately, i recently recognized a retained metallic fragment on a different patient from a broken wire contained within the suture anchor delivery device.This generated a retrospective review of all of my hip arthroscopy patients to date (approximately 76 patient).Patient was one of four patients in which this retained broken wire was identified.This wire is outside of the articular surfaces and has not migrated on follow-up x-rays.I do not think this will cause any problems, symptoms or negatively impact her outcome.I recommended continued observation at this time as i feel attempted retrieval of this metallic fragment would cause more harm than any potential benefit.Will continue to follow her as previously scheduled.She was understanding and in agreement.

• Brand Name: CINCHLOCK
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 6584116
• MDR Text Key: 75743390
• Report Number: 6584116
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CAT02462
• Device Catalogue Number: CAT02462
• Device Lot Number: 16060201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR