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

Model Number	254809
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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
It was reported by the sales rep via phone that during an acl procedure their intrafix advance br screw 10x30mm with large sheath when the screw was inserted into the sheath, the sheath did not hold in the patient.When they tried their 10x23mm milagro advance interference screw that also did not hold in the patient.The procedure was complete with a competitor's device with a new bone hole created.There was no patient consequences but there was a 20 minute surgical delay to the case.The sales rep stated that the patient was an older person with soft bone quality.The sales rep stated that the devices were discarded by the customer.This report is for one (1) intrafx advbr scw10x30w/lgshth.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.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.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.No nonconformances were identified for this part-lot number combination per qlik query executed 08/11/2019.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).

• Brand Name: INTRAFX ADVBR SCW10X30W/LGSHTH
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8895291
• Report Number: 1221934-2019-58005
• Device Sequence Number: 10835249
• Product Code: MAI
• UDI-Device Identifier: 10886705026685
• UDI-Public: (01)10886705026685
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 04/30/2021
• Device Model Number: 254809
• Device Catalogue Number: 254809
• Device Lot Number: L863005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention