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

Catalog Number	72203982
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the suture broke off (anchor).The suture was removed from the patient's anatomy.Anchor remain in the patient, additional loose ultratape suture was used to complete the surgery.No patient injuries or delay was reported.
Additional Manufacturer Narrative
The reported 4.5 mm pk sa healicoil intended for use in treatment, has not been returned for evaluation.Without the return of the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the suture broke.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of sharp instruments to manage or control the suture.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a rotator cuff repair, the suture broke off anchor.The suture was removed from the patient's anatomy.Anchor remain in the patient, additional loose ultratape suture was used to complete the surgery.No patient injuries or delay was reported.

• Brand Name: HEALICOIL PK 4.5MM W/ ULTRA TAPE CBRD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8762789
• Report Number: 1219602-2019-00782
• Device Sequence Number: 2039663
• Product Code: MBI
• UDI-Device Identifier: 00885554032130
• UDI-Public: 00885554032130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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 Catalogue Number: 72203982
• Device Lot Number: 2021339
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1