MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203981
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder procedure, the tip of the healicoil anchor came apart from the rest of the anchor body.The hole was punched to the correct depth and the angle of insertion was inline.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.¿.
Additional Manufacturer Narrative
One healicoil pk 4.5mm suture anchor used in treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Batch review was unattainable without a verifiable lot number reported.Instructions for use contains recommendations and precautionary statements for proper use of product.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10300055
• Report Number: 1219602-2020-01088
• Device Sequence Number: 667235
• Product Code: MBI
• UDI-Device Identifier: 00885554032123
• UDI-Public: 00885554032123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72203981
• Device Catalogue Number: 72203981
• Device Lot Number: 642189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention