MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRAFX ADV POLYPROSHTHSM 30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254825
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure when doing the tibial side their pp intrafix advance sheath small 30 mm protruded through the tunnel and joint space.The surgeon used a probe to find the device and remove it from the joint space with no further issues.The procedure was completed with another like device using the same tunnel with no patient harm but there was a five minute surgical delay to the case.The sales rep stated that the facility is a teaching hospital and that a resident was doing this part of the case so there was a technique issue.The device was discarded by the customer.
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.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.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.The sales rep stated that the facility is a teaching hospital and that a resident was doing this part of the case so there was a technique issue, therefore is a possible root cause of the reported problem.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.No nonconformances were identified for this part-lot number combination per qlik query executed on (b)(6) 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 ADV POLYPROSHTHSM 30MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9169340
• Report Number: 1221934-2019-58874
• Device Sequence Number: 16740082
• Product Code: MBI
• UDI-Device Identifier: 10886705027521
• UDI-Public: 10886705027521
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 09/13/2019

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: 05/31/2020
• Device Catalogue Number: 254825
• Device Lot Number: L458422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1