SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
|
Back to Search Results |
|
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 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 unknown, however, no further complications have been reported.
|
|
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.Per instructions for use: ¿if more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Breakage of the suture anchors can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.Recommended prep instrument for the 5.5 mm anchor used on normal bone condition is a 3.8 mm tapered awl.Communication relayed use of a 5.5 mm awl.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.In post revision the patient presented 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.The anchors were retained and therefore its not believed to be related to the reported rejection.
|
|
Event Description
|
It was reported that 6-7 weeks after shoulder surgery performed on 25 oct 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 presents 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.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|