MAUDE Adverse Event Report: DEPUY MITEK LLC US ABSOLUTE INTSCR 10X30MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	254508
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the complaint device was received and inspected.Visual observation under magnification of the reveals that there were no defects observed.To test the functionality of the device the screw was tested with hex driver,the driver was inserted into the screw and found to fixed tight and correct.Hence,the complaint cannot be confirmed.Since the reported condition was not confirmed and no defect found the root cause for the reported failure cannot be determined and manufacturing record evaluation was not required.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Udi: (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate via e-mail that during a a.C.L.Surgery the absolute interference screw was stuck in the screw driver and did not got deployed in the tibia bone during the fixation of graft.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9126196
• Report Number: 1221934-2019-58627
• Device Sequence Number: 14068293
• Product Code: MAI
• UDI-Device Identifier: 10886705013005
• UDI-Public: 10886705013005
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: 05/31/2021
• Device Catalogue Number: 254508
• Device Lot Number: L896365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1