MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP DS W/ORTHOCORD *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222981
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6l28939), and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes (b)(4) will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported from (b)(6) that during hip surgery on (b)(6) 2020, it was observed that once the anchor device had been implanted, the double suture was already tied.According to the report, the suture had to be cut and was left implanted.A new implant was used to complete the surgery successfully with a five minute delay.There were no fragments were generated.There was no additional medical intervention reported.There were no adverse patient consequences reported.No additional information was provided.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10521354
• Report Number: 1221934-2020-02542
• Device Sequence Number: 2902970
• Product Code: MAI
• UDI-Device Identifier: 10886705008599
• UDI-Public: 10886705008599
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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 Expiration Date: 09/30/2022
• Device Model Number: 222981
• Device Catalogue Number: 222981
• Device Lot Number: 6L28939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR