MAUDE Adverse Event Report: DEPUY MITEK LLC US 6X12 MILAGRO INTERFRENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231813
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.(b)(4).
Event or Problem Description
It was reported by the affiliate via the complaint submission tool, that during an acl repair the surgeon was connecting the 12mm screwdriver with the screw, the screw broke in the middle of the length.The affiliate reported a surgical delay did not occur and fragments were not generated.It was also reported additional surgical intervention was not required and the procedure was successfully completed but additional details could not be provided.
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.The date of event was reported as (b)(6) 2019 on the initial report and has been updated as (b)(6) 2019.Event: subsequent follow-up with the customer, additional information was received.It was reported that there was no surgical delay in the procedure.It was reported that an alternative product was not readily available.It was reported that the case was completed by leaving the screw in the femoral tunnel.It was reported that the same bone hole was used to complete the procedure.It was reported that all the broken pieces were removed from the patient with no issues.It was reported that there were no broken pieces because the screw has broken in the tunnel on the distal part.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary = > according to the information provided, it was reported that the device broke during the procedure.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However a photo was provided.Upon visual inspection of the photo, it's visible just a little portion of the device which showed a little crack from medial to external aspect.It's not clear if the device broke completely.Therefore the reported complaint was confirmed.The photo do not provide enough evidence to determine root cause.A possible root cause can be associated to an excessive force applied during the insertion and/or an incorrect insertion angle, however it cannot be conclusively affirmed.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device [4l02038] number, and no non-conformances were identified.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.Device history lot = > a manufacturing record evaluation was performed for the finished device [4l02038] number, and no non-conformances were identified.

• Brand Name: 6X12 MILAGRO INTERFRENCE SCREW
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9404767
• Report Number: 1221934-2019-59821
• Device Sequence Number: 1672436
• Product Code: HWC
• UDI-Device Identifier: 10886705021956
• UDI-Public: 10886705021956
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K143660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2019

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: 02/28/2022
• Device Model Number: 231813
• Device Catalogue Number: 231813
• Device Lot Number: 4L02038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 01/23/2020; 01/27/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/23/2019; 01/24/2020; 01/28/2020
• Patient Sequence Number: 1