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

Model Number	72201806
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a wrist stabilization surgery, a hole was drilled and when the raptormite anchors were being screw in they got fractured.No significant delay or other complications were reported.Smith and nephew back-up device was available to complete the surgery.All the broken pieces were removes from the patient's anatomy using tweezers.No additional bone hole was required to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images confirmed the part and batch numbers.The anchor was not visible in the photos.A visual inspection revealed that the device was returned with the sutures and anchor fragments.The anchor had fractured proximal to the eyelet, and the distal fragment was still attached to the sutures.The proximal fragment had a severe bend at the connection point to the insertor.There was significant debris on the sutures and shaft.There were not any visual problems with the insertor.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: product should be stored at ambient temperature.Prolonged exposure of anchors to elevated temperatures may lead to degradation of the anchor.Breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith & nephew drill prior to implantation.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.The complaint was confirmed.Factors that could have contributed to the reported event include off-axis insertion, improper preparation of the insertion site, excessive force or bending during use, or improper storage of the device.No containment or corrective actions are recommended at this time.

• 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 blvd.; mansfield MA 02048
• MDR Report Key: 11319558
• Report Number: 1219602-2021-00310
• Device Sequence Number: 19666814
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2025
• Device Model Number: 72201806
• Device Catalogue Number: 72201806
• Device Lot Number: 2050878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 78