MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203801
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during arthroscopic rotator cuff repair procedure, when the surgeon inserted the anchor into the site, the middle of anchor got broken.Twenty minutes procedure delay was reported with no patient injuries.
Additional Manufacturer Narrative
Device was returned for evaluation.The device is used.The complaint said: ¿it was reported that during arcr procedure, when the surgeon inserted the anchor into the site, the middle of anchor got broken.20 minutes procedure delay was reported with no patient injuries¿.Spiral threads are fractured.There are proximal threads that are sliced from contact with another instrument or bone.The anchor has encountered force and compression.It was later confirmed that the broken pieces were not all retrieved.Details relayed that patient bone density was normal.The accompanying ifu recommends either a 5.5 mm or disposable threaded dilator is for approved for normal bone site prep.The communications said ¿a 3.8mm tapered awl was used for prep hole¿.No root cause associated with the manufacture of this device could be supported nor proven.Use error may have been a contributing factor to the event.Complaint history search revealed no additional complaints for this production lot.
Event or Problem Description
It was reported that not all broken pieces could be retrieved from the patient.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6875876
• Report Number: 1219602-2017-01162
• Device Sequence Number: 1142266
• Product Code: MAI
• UDI-Device Identifier: 00885554031430
• UDI-Public: (01)00885554031430(17)190111(10)50582053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: 01/11/2019
• Device Catalogue Number: 72203801
• Device Lot Number: 50582053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR