MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL INTRAFX ADVBR SCW10X30W/LGSHTH; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	254809
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part number, lot number combination per qlik query executed on (b)(6) 2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi:(b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the sales rep's 10x30 intrafix advance screw and 9x30 intrafix advance screw sheaths broke during insertion.The sales rep stated that the implants were fully removed from the patient with a hemostat.The implants were being used in conjunction with a size 9 graft, a 9.5 tunnel, and a large trial.The sales rep stated that the insertion of the implants was not off axis.The case was completed with another like-implant in the same bone hole with no patient harm or delay.The implants were discarded by the customer.

• Brand Name: INTRAFX ADVBR SCW10X30W/LGSHTH
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8609921
• Report Number: 1221934-2019-57144
• Device Sequence Number: 13976184
• Product Code: MAI
• UDI-Device Identifier: 10886705026685
• UDI-Public: 10886705026685
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

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 Catalogue Number: 254809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1