MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72201806
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 3.0 pk raptormite w/needles was returned for evaluation.Visual assessment of the device shows approximately.045 of the proximal end of the anchor has broken where it interfaces with the inserters distal tip.The break is angular in nature.The broken portion of the anchor was not returned for examination.Dimensional assessment of the remaining portion of the anchor was found to meet print specifications.The condition of the anchor indicates it was subjected to excessive force and off axis insertion during use.Per the device instructions for use: ¿ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.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.(b)(6).
Event or Problem Description
It was reported that during a lateral collateral ligament repair surgery the nail body escapes from bone.Product was removed and a back-up was used.No significant delay reported and no patient injuries.Results of investigation have concluded that this device broke as it was submitted to excessive force and off-axis insertion, which makes it a reportable event.

• Brand Name: RAPTORMITE 3.0 PK W/NDL, 2 #0 ULTRABRA
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8880855
• Report Number: 1219602-2019-00941
• Device Sequence Number: 2047975
• Product Code: MBI
• UDI-Device Identifier: 03596010619082
• UDI-Public: 03596010619082
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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 Expiration Date: 06/25/2023
• Device Catalogue Number: 72201806
• Device Lot Number: 50743464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR