MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOCRYL INTSCR 8X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by our technical assistant via email, in the moment of the surgical procedure of anterior cruciate ligament (acl), when introducing the bioabsorbable screw, it did not support, breaking a part.
Additional Manufacturer Narrative
Additional narrative: investigation summary = > the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.Multiple follow-ups were made to obtain additional information regarding the event but no response was received.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 (4l01828), and no non-conformance was identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek 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.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10487545
• Report Number: 1221934-2020-02379
• Device Sequence Number: 11777298
• Product Code: MAI
• UDI-Device Identifier: 10886705010608
• UDI-Public: 10886705010608
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 02/28/2022
• Device Model Number: 231710
• Device Catalogue Number: 231710
• Device Lot Number: 4L01828
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1