MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFIX 2.7MM BTB BR XPIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210815
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during an anterior cruciate ligament reconstruction when opening the packaging of the rigidfix biocryl 2.7 mm btb cross pin kit, it was noticed that the anchor was missing.The device was received and evaluated.When performing the visual inspection, it could be observed that only one sleeve and the interlocking trocar were returned, however, the second sleeve and the 2 cross pins which are part of the whole kit were not returned, also, these devices were not returned along with their original packaging.Upon visual inspection, the sleeve and the trocar were found jammed, it could be observed stretch marks all over the sleeve, also on the trocar which is an evidence that the kit was used.A manufacturing record evaluation was performed for the finished device 6l87506 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Considering that the set was brand new, the original packaging items should have been returned in order to verify the missing product.This complaint cannot be confirmed.The possible root cause for the jammed condition can be attributed to procedural variables, such handling of the device or product interaction during procedure.We can relate this issue to a bad axis alignment of the drill at the moment of insertion, the bending force applied and the higher spinning speed of the drill can contribute to the jamming condition of the sleeve and the trocar.However, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the sales rep that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that the anchor on the rgdfix 2.7mm btb br xpin kit was missing upon opening its package.During in-house engineering evaluation, it was determined that the sleeve and the trocar were jammed.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: RGDFIX 2.7MM BTB BR XPIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12488171
• Report Number: 1221934-2021-02730
• Device Sequence Number: 4030207
• Product Code: MAI
• UDI-Device Identifier: 10886705001293
• UDI-Public: 10886705001293
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 210815
• Device Catalogue Number: 210815
• Device Lot Number: 6L87506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1