MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REGENESORB SUTURE ANCHOR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72205020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Catalog number: the following are the part numbers were reported: 72205020 and 72204984.However, it is unknown which of the two failed.Unique identifier (udi) #: udi for the part numbers reported: 72205020 (udi: (b)(4)) and 72204984 (udi: (b)(4)).
Event or Problem Description
It was reported that on pmcf review microraptor knotted regenesorb, was found that during a procedure to treat a slap injury, while using one (1) microraptor knotted regenesorb and 1 microraptor regenesorb with one ultrabraid anchors, one of the anchors didn't work and broke off but it is unknown which one.It is unknown how was the event treated.After the procedure the patient reported poor compliance.Patient also had conditions unrelated to the devices as muscular weakness and pain.Patient outcome is unknown.No further information is available.
Additional Manufacturer Narrative
H6, health effect - clinical code was updated.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.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.Insufficient product identification information was provided and thus a product print specification review could not be conducted.A clinical review states that no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the post-market clinical follow up activity (pmcf) was anonymous.The anchors are implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.Should any additional clinical information be provided this complaint will be re-evaluated.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: UNKN REGENESORB SUTURE ANCHOR
• Common Device Name: 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: 16308029
• Report Number: 1219602-2023-00146
• Device Sequence Number: 20366411
• Product Code: MAI
• UDI-Device Identifier: 00885556722510
• UDI-Public: 00885556722510
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: 72205020
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male