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

Catalog Number 72203708

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during a rotator cuff repair procedure, when screwing in, the healicoil screw thread was unscrewed.The anchor broke in the operative field, but all pieces were removed.A back-up device was available to complete the procedure without significant delay.No patient injuries were disclosed.

Manufacturer Narrative

The reported 5.5mm healicoil rsb sa, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the anchor broke in the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: the insertion site not prepared with the recommended smith & nephew instrumentation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8513560
• MDR Text Key: 141939363
• Report Number: 1219602-2019-00424
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Catalogue Number: 72203708
• Device Lot Number: 50739497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR