MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 10X30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231823
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.
Event or Problem Description
It was reported that there was screw breakage.The screw broke to two pieces during acl reconstruction.The broken pieces were retrieved.There was no report on patient injury.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial or first follow-up medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is not currently available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.During subsequent follow-up with the customer additional information was obtained.The reporter clarified that the breakage of the screw device did not result in a greater than 30-minute delay in the procedure.It was reported that an unspecified spare device was available for use.It is unknown if there were any procedural or patient anatomy factors which may have contributed to the breakage.It is unknown if any portion of the device remained in the patient.It was reported that there was no surgical intervention planned.It was reported that there was no impact to the patient.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device evaluation: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the screw was broken in 4 separate pieces.It is possible that proper tapping was not performed, and the screw was being inserted into bone of hard quality.Therefore, a potential root cause for the reported failure could be inadequate preparation of the surgical site.However, we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.Further, a review into the depuy synthes mitek complaints system revealed a similar complaint for this lot of devices with the product code that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).The expiration date is not currently available.

• Brand Name: MILAGRO ADVANCE SCREW 10X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7542845
• Report Number: 1221934-2018-50836
• Device Sequence Number: 1528615
• Product Code: HWC
• UDI-Device Identifier: 10886705022281
• UDI-Public: 10886705022281
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2018

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 Catalogue Number: 231823
• Device Lot Number: L421938
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 06/11/2018; 05/25/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/26/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1