MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE; STAPLE, FIXATION, BONE

Model Number 72201995

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  Injury  

Event Description

It was reported that, during a shoulder cuff repair surgery, the 'osteoraptor' anchor came out after the tightening.The procedure was completed with a non-significant delay using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a shoulder cuff repair surgery, the 'osteoraptor' anchor came out after the tightening.The procedure was completed with a non-significant delay using a smith and nephew back up device in the originally drilled bone hole.A single void was left.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Internal complaint reference: (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Per additional information received, the backup anchor was used in the same bone hole, therefore no bone voids were left in the patient.This event did not required any medical intervention to preclude damage nor will it contribute to serious injury.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE
• Type of Device: STAPLE, FIXATION, BONE
• 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: 13530370
• MDR Text Key: 285615467
• Report Number: 1219602-2022-00213
• Device Sequence Number: 1
• Product Code: JDR
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201995
• Device Catalogue Number: 72201995
• Device Lot Number: 2068911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 79 KG