MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203379

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 12/17/2018

Event Type  Injury  

Event Description

It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patient's shoulder.Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is unknown, however, no further complications have been reported.

Event Description

It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patients shoulder.Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is a full passive range of motion but limited active range of motion, allowed to gradually resume activity as tolerated, with no trauma during her recovery.

Manufacturer Narrative

One healicoil pk 5.5mm-2 ub blue-cobraid device was reported on.The complaint was received from rotation medical and shared with smith and nephew.The complaint indicated that a massive tear was repaired with multiple suture anchors.5 complaints were opened to record the revision and the smith and devices used.A subsequent ¿implant rejection¿ was noted with redness, swelling and pain.Due to product unavailability, the complaint could not be visually evaluated.Evaluation results were based upon information relayed.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1.Damaged or use of other than recommended prep instrument size or types.2.Pressure or excess torque applied.3.Inadequate bone quality resulting in anchor pullout or loss of fixation.4.Unexpected bone condition/density.5.Use of sharp instruments to manage or control the suture.Final product met specifications upon release to distribution.There is no objective evidence to suggest a direct link between the surgical site infection (ssi) and products used during the procedure.

• Brand Name: HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8284551
• MDR Text Key: 134314323
• Report Number: 1219602-2019-00121
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554026306
• UDI-Public: 00885554026306
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72203379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 62 YR