MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN PEEK INTERFERENCE SCREW; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 04/06/2020

Event Type  Injury  

Event Description

It was reported that on literature review arthroscopic treatment of type ii superior labral anterior to posterior (slap) lesions in a younger population: minimum 2-year outcomes are similar between slap repair and biceps tenodesis, 1 patient had a postoperative superficial infection after a bicep tenodesis procedure using a 8mm biceptor peek interference screw.The event was successfully treated with antibiotics.No further information is available.

Manufacturer Narrative

(b)(4).Article: dunne, k.F., knesek, m., tjong, v.K., riederman, b.D., cogan, c.J., baker, h.P.,.& terry, m.A.(2021).Arthroscopic treatment of type ii superior labral anterior to posterior (slap) lesions in a younger population: minimum 2-year outcomes are similar between slap repair and biceps tenodesis.Knee surgery, sports traumatology, arthroscopy, 29(1), 257-265.

Manufacturer Narrative

H10: h3, h6:the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states it was communicated that the requested clinical documentation was not available; therefore, contributing clinical factors could not be concluded and it cannot be concluded that there was a malperformance of the s+n device.With the limited information provided, the patient impact beyond the reported (¿minor¿) infection and subsequent antibiotic treatment cannot be determined.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.No further medical assessment can be rendered at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKNOWN PEEK INTERFERENCE SCREW
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15612194
• MDR Text Key: 301809948
• Report Number: 1219602-2022-01530
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• 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 Outcome(s): Other