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

Catalog Number CAT02462

Device Problems Entrapment of Device (1212); Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/24/2017

Event Type  malfunction  

Event Description

Also see report #(b)(4); same patient, different lot #.Unintentional retained object.Postop surgical procedural note -.Repairing the labrum.Three cinchlock suture anchors were ultimately necessary for the labral repair.A base stitch pattern was utilized.The suture was passed through the labrum, followed by drilling and subsequent anchor placement to stabilize the labrum back to the acetabular rim.This sequence was then repeated 2 additional times to complete our 3-anchor repair.This achieved appropriate stabilization of the labrum back to the acetabular rim.The labrum was then probed and noted to be stable.From surgeon: 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.I have disclosed this to the patient.

• 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: 6584132
• MDR Text Key: 75743908
• Report Number: 6584132
• 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 Catalogue Number: CAT02462
• Device Lot Number: 17010901
• 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: 18 YR
• Patient Weight: 60