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

Model Number	72203706
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder arthroscopy,anchor broke while it was being placed.Broken pieces were removed and operation was completed with titanium anchor.No patient injury was reported.
Additional Manufacturer Narrative
One 5.5mm healicoil rg sa anchor system was returned for evaluation.Visual assessment confirmed the reported breakage.Numerous threads of anchor have broken off.The broken pieces were not returned for evaluation.The anchors distal end is bent and cracked.Dimensional assessment is prohibitive due to the anchors condition.With the limited clinical details regarding patient bone quality and site preparation no root cause can be determined.

• Brand Name: HEALICOIL RG SA 5.5MM W/2 UB-BL CBRD BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7632624
• Report Number: 1219602-2018-00805
• Device Sequence Number: 1754383
• Product Code: MAI
• UDI-Device Identifier: 00885554031416
• UDI-Public: (01)00885554031416(17)201004(10)50689100
• Combination Product (Y/N): N
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 10/04/2020
• Device Model Number: 72203706
• Device Catalogue Number: 72203706
• Device Lot Number: 50689100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR