MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5HLX ADV PK ANC-DYNA W/ NDL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222027
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/09/2020
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.Additional narrative: udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported by the affiliate in (b)(6) that during an ankle reconstruction surgery, a 4.5mm healix advance¿ peek anchor with dynacord¿ suture (blue, white/blue/green), with needles (mo-7) cracked and broke upon insertion when surgeon applied torque.Surgeon has pre-drilled a hole prior to insertion.To complete procedure a new anchor was opened and existing hole was dilated further with awl tap to accommodate anchor.There was a surgical delay of one minute with no patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary according to the information provided, it was reported that during an ankle reconstruction a 4.5mm healix advance anchor with dynacord¿ suture (blue, white/blue/green), with needles (mo-7) cracked and broke upon insertion when surgeon applied torque.Surgeon has pre-drilled a hole prior to insertion.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 was observed that the anchor was cracked in the proximal part but held in place by the suture.The photo provide evidence of damage in the anchor; therefore, the complaint reported can be confirmed.As a result, we cannot determine a root cause for the reported failure, but the possible could be related when applying excessive tension from pulling suture back or with off axis insertion; however, it cannot be conclusively affirmed.Hands on analysis should provide more evidence to be able to discern a root cause.A manufacturing record evaluation was performed for the finished device lot number:4l01766, 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.

• Brand Name: 4.5HLX ADV PK ANC-DYNA W/ NDL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10206770
• Report Number: 1221934-2020-01675
• Device Sequence Number: 2095369
• Product Code: MAI
• UDI-Device Identifier: 10886705029433
• UDI-Public: 10886705029433
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 222027
• Device Catalogue Number: 222027
• Device Lot Number: 4L01766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1