MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CORTICAL FXATION FXD LOOP 15MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	232009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.No lot numbers were supplied which precludes conducting a device history record (dhr) review.At this point, 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.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate via email that a report received for iis (investigator initiated studies) which is an acl registry in (b)(6) was uploaded.The registry goal is to capture all acl procedures performed in (b)(6) and currently have 117 participating surgeons.All data provided from participating surgeons is de-identified and captures all procedures/devices across all industry manufacturers.On opening the report to review the information, affiliate identified the implant complication rates for all depuy products currently captured in the registry on the last page of the report.On discussion with medical director, the information is being provided by the affiliate to the product safety for entry into the complaints system as ¿information only¿ given the data is cumulative over the duration of the registry; no further information is available.There is the potential of duplicative reporting if any of these cases have already been individually (reported to the company) at the point of occurrence (from either surgeon/employee clinical specialist) as stated by the affiliate.The report states that 13 cortical fixation fxd loop 15mm; product code: 232009, failed due to unknown reasons.Re-surgery was required to repair the failure.

• Brand Name: CORTICAL FXATION FXD LOOP 15MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8375612
• Report Number: 1221934-2019-56494
• Device Sequence Number: 2198656
• Product Code: MBI
• UDI-Device Identifier: 10886705022649
• UDI-Public: 10886705022649
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130814
• 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
• Report Date (Section B): 11/30/2018

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 Catalogue Number: 232009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 02/27/2019
• Patient Sequence Number: 1