MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN PEEK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Alteration in Body Temperature (4568)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).Article: khuntia, s.K., patro, b.P., sahu, s., & patel, b.K.(2022).Non-suppurative tissue reaction to polyether ether ketone anchor in rotator cuff repair.Journal of orthopaedic case reports, 12(8), 47.H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that on literature review non-suppurative tissue reaction to polyether ether ketone anchor in rotator cuff repair, 1 patient underwent a mini open rotator cuff repair with two(2) footprint pk suture anchors.The patient had pain and mild rise of local temperature over shoulder 3 weeks after the procedure.Nearly 3 months after operation, he presented with redness and serous discharge from stitch site and it was treated with an incision and drainage presuming all is not well.On incision, we found nearby muscles and soft-tissue healthy with collection of some pale-yellow semisolid substance near the screw site.Empirically, broad-spectrum antibiotic was administered.The patient was better than before but there was serous discharge from the stitch margin.Nearly 4 months after first operation, patient had another debridement under general anesthesia.It was found similar straw color semisolid inconsistency material near the screw site.Nearby, muscles were red, healthy, and contractile to stimulation.All the visible sutures and peek screw were removed.Patient improved from his symptoms and wound healed normally.No further information is available.

• Brand Name: UNKNOWN PEEK SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18907764
• MDR Text Key: 337731246
• Report Number: 1219602-2024-00494
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male