MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 6-7MMX30MMTPRSCR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	254622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
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) - incomplete.The expiration date is not currently available.
Event or Problem Description
It was reported by our affiliate that postoperative screw breakage.The patient accepted reconstruction of cruciate ligament on (b)(6) 2018.No anomaly was occurred in procedure.After operation patient returned hospital for check and x-ray report indicated screw broke.No additional treatment was given.The patient has no discomfort.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded by the customer therefore, device is not available for a physical evaluation.It was reported that the implant device broke post-surgery, with the use of x-ray.No issues during the procedure was reported.As reported, the patient is stable and not experiencing any discomfort.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review into the depuy mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.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).
Event or Problem Description
It was reported by our affiliate that postoperative screw breakage.The patient accepted reconstruction of cruciate ligament on (b)(6) 2018.No anomaly was occurred in procedure.After operation patient returned hospital for check and x-ray report indicated screw broke.No additional treatment was given.The patient has no discomfort.Additional information from affiliate: the failure was detected by an x-ray report.Unknown if the implant pulled out.Unknown if a revision is planned.Unknown if there is an attributable cause for the failure (e.G.Trauma, poor bone quality, non-compliance).Unknown if there is any patient impact.Unknown if there was a resulting harm to the patient at the time this complaint is capture/reported.

• Brand Name: BIOINTRAFIX 6-7MMX30MMTPRSCR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7560910
• Report Number: 1221934-2018-51146
• Device Sequence Number: 16187255
• Product Code: HWC
• UDI-Device Identifier: 10886705013197
• UDI-Public: 10886705013197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 254622
• Device Lot Number: L190129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention