MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203983
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 5.5 mm pk sa healicoil anchor was returned for evaluation.Visual assessment of the device confirmed its breakage.Approximately 90% of the anchors threads have been broken off and were not returned.Dimensional assessment is prohibitive due to the anchors condition.The area of breakage is heavily burnished indicative of contact with the cortical layer of bone.This indicates the anchor were likely off axis during insertion.Per the device ¿establish axial alignment of the suture anchor to the insertion site.While supporting the insertion site, rotate the anchor clockwise into the site.Continue to rotate the anchor until the horizontal laser mark is flush with the bone surface¿.
Event or Problem Description
It was reported that the surgery was prepared with gold awl, implanted about 80% of the way when it was notice that all the threads had sheared off the body of the anchor.It was used the same bone hole with the replacement anchor.Nor delay or patient injury reported.

• Brand Name: HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7639279
• Report Number: 1219602-2018-00824
• Device Sequence Number: 2512726
• Product Code: MBI
• UDI-Device Identifier: 00885554032109
• UDI-Public: (01)00885554032109(17)221005(10)50689113
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: 72203983
• Device Catalogue Number: 72203983
• Device Lot Number: 50689113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR