MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT 5.5MM FP SUT ANC SL ACH TENDON RE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203798

Device Problem Mechanics Altered (2984)

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

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the suture would not lock into the anchor and kept slipping out.A backup device was available to complete the procedure without delay or patient impact.

Manufacturer Narrative

Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.

• Brand Name: KIT 5.5MM FP SUT ANC SL ACH TENDON RE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7051313
• MDR Text Key: 92974731
• Report Number: 1219602-2017-01454
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554029970
• UDI-Public: (01)00885554029970(17)210722(10)50668015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Catalogue Number: 72203798
• Device Lot Number: 50668015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Date Device Manufactured: 06/06/2017
• 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