MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72201541
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery, the anchor broke.A backup device was available to complete the procedure with no delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.One 72201541 bioraptor suture anchor device reported on.It was used for treatment but was not returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.It provides technique driven instruction.Per instructiosn for use: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.Do not alter the implant or instrumentation, otherwise performance may be compromised.¿ complaint history review indicated similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product material met quality specification requirements of validated design.No root cause related to the manufacturing was confirmed.
Additional Manufacturer Narrative
The reported 72201541 2.3 bioraptor pk suture anchor, used in treatment, was returned for evaluation.The information provided states: ¿during surgery, the anchor broke¿.Visual assessment confirms complaint.Remaining part of the anchor is free from the inserter.The broken piece was not returned.The major diameter of the anchor was found to meet print specifications.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: pathological conditions of the bone that would prevent secure fixation.Improper site preparation.The instruction for use outlines 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.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.

• Brand Name: BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9815089
• Report Number: 1219602-2020-00504
• Device Sequence Number: 14220184
• Product Code: MBI
• UDI-Device Identifier: 03596010595072
• UDI-Public: 03596010595072
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071586
• 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,Followup
• Report Date (Section B): 06/29/2020

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: 05/15/2023
• Device Model Number: 72201541
• Device Catalogue Number: 72201541
• Device Lot Number: 50735704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 06/25/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/17/2020; 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1