MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS; FASTENER,FIXATION,NONDEGRADABLE, SOFT TISSUE

Model Number	222242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: hwc, jdr.Complainant part is not expected to be returned for manufacturer review / investigation.Facility information not available.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported during an achilles repair procedure on (b)(6) 2019, the sutures break when pulling sutures for closure.The surgery was completed successfully.Surgical delay and patient status are unknown.This is report 1 of 1 for.
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.Additional narrative: investigation summary: 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, the suture was observed completely broken.The reported complaint was confirmed.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.A non-conformance search was performed for this product code 222242, lot #2l82128 combination 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: no nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6) 2019.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.

• Brand Name: 5.5 HEALIX TI ANCHR W/OC +NDLS
• Common Device Name: FASTENER,FIXATION,NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8975309
• Report Number: 1221934-2019-58222
• Device Sequence Number: 3039437
• Product Code: MBI
• UDI-Device Identifier: 10886705007882
• UDI-Public: (01)10886705007882
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K082282
• 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,Followup
• Report Date (Section B): 08/12/2019

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: 12/31/2021
• Device Model Number: 222242
• Device Catalogue Number: 222242
• Device Lot Number: 2L82128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 11/06/2019
• Patient Sequence Number: 1