MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72201995

Device Problem Break (1069)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported that during an arthroscopy, the osteoraptor anchor broke while implantation.The procedure was completed using a s+n back up device.It is unknown if there was a delay.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H2: additional information: a1, a2, a3, a4, b1, b2, b5, e1 and ,h1, h6.

Event Description

It was reported that during an arthroscopy, the osteoraptor anchor broke while implantation.The broken pieces were removed from patient with tweezers and suction.A void was left in the patient.The procedure was completed with a delay of less than 30 minutes using a smith and nephew back up device in an additional bone hole.No further complications were reported.

• Brand Name: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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: 19122933
• MDR Text Key: 341014766
• Report Number: 1219602-2024-00809
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615565
• UDI-Public: 03596010615565
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201995
• Device Lot Number: 2084049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/28/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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): Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 69 KG