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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

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SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON Back to Search Results
Catalog Number 72205307
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2023
Event Type  malfunction  
Event Description
It was reported that during a shoulder arthroscopy, the bioinductive implant began to disintegrate in the joint of the patient; the surgeon removed as much frayed tissue on the implant as possible using a werewolf wand.The surgeon had ample time to deliver the tendon anchors and bone anchors within the right timeframe.The procedure was completed using the same reported device.There was a delay of less than 30 minutes, and no further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
Event Description
It was reported that during a shoulder arthroscopy, the bioinductive implant began to fray along the border in the joint of the patient; the surgeon removed as much frayed tissue on the implant as possible, nearly 50% of it, using a werewolf wand.The surgeon had ample time to deliver the tendon anchors and bone anchors within the right timeframe.The procedure was completed using the same reported device.There was a delay of less than 30 minutes, and no further complications were reported.
 
Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the implant specifications found that the staple pull through strength and tensile strength requirements are specified, and a certificate of compliance is required.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
 
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Brand Name
BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG
Type of Device
MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key18432326
MDR Text Key331928166
Report Number3003604053-2024-00001
Device Sequence Number1
Product Code OWY
UDI-Device Identifier00885556745038
UDI-Public885556745038
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K140300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/21/2024
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
Device Operator Health Professional
Device Catalogue Number72205307
Device Lot Number2081252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received01/02/2024
Supplement Dates Manufacturer Received01/02/2024
02/16/2024
Supplement Dates FDA Received01/16/2024
02/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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