MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTERFERENCE SCREW, 8 X 30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231815
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.The batch review 3434798 showed that the devices were conformed to in process and finished goods specifications when released to stock the 28 june 2010.Expiration date: 2013-06 (according to retained labels).No nc was opened.Ri was opened relating to complete clean down of the mitek clean room with no link with this complaint.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint."our results indicate that this batch of product was processed with an unrelated (non-conformance / out of tolerance) to the reported incident and therefore there is no internally assignable cause for the reported problem." further, a review into the depuy mitek complaints system revealed 1 similar complaint for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, 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.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
The sales rep reported that during an acl procedure, the customer's biointrafix large sheath was crushed when taken out of the package.The packaging was not damaged.The surgeon then went to insert their 8x30mm milagro interference screw and upon insertion it broke into pieces.The surgeon removed all broken fragments of the anchor and went to insert their biointrafix tapered screw and it also broke into pieces.The surgeon removed all broken fragments of the second anchor and used a competitor's anchor to complete the procedure.The sales rep stated the procedure was delayed 20 minutes due to this and all complaint devices were discarded.No patient information could be provided other than it being good bone.No pictures were available.Please see also medwatch report 1221934-2018-51117.

• Brand Name: MILAGRO INTERFERENCE SCREW, 8 X 30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7660662
• Report Number: 1221934-2018-51078
• Device Sequence Number: 19335809
• Product Code: MAI
• UDI-Device Identifier: 10886705010783
• UDI-Public: 10886705010783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2013

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: 06/01/2013
• Device Catalogue Number: 231815
• Device Lot Number: 3434798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2013
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1