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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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) - incomplete.The expiration date is not currently available.Associated medwatch:1221934-2018-51908; 1221934-2018-51916.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure when inserting their intrafix advance sheath small 30mm with their peek intrafix advance screw 8x30mm, the surgeon did not feel that the fixation was solid.The surgeon then tried inserting a big screw their peek intrafix advance screw 9x30mm and still felt that the fixation was not solid so he used a backup tibial fixation.When the surgeon while using the scope, he then realized that the sheath had been pushed up into the joint space.The fixation was removed with no issues and the procedure was completed with the older version of the intrafix sheath and screws with a backup tibial fixation.The sales rep confirmed that the same bone holes were used to finish the case with no harm to the patient but there was a five minute delay to remove the fixation and replaced with a new one.The patient's bone quality was average and the sales rep confirmed no debris left in patient.The sales rep stated that the two screws were discarded but the sheath will be returning for evaluation.
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.
Event or Problem Description
Additional event information received on 05/22/2018.No replacements were ordered per the sales rep's request instead a trunk stock adjustment has been requested on behalf of the rep per their request.
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 was received and inspected.The complaint can be confirmed.It was observed that the sheath was heavily deformed, which was most likely caused during the surgery.It was stated that the surgeon used a larger screw size, and still could not fit the device into the bone hole as desired.Therefore, it is possible that the surgeon did not prepare the bone hole properly and created a bone hole that was too large.This would explain how even the larger screw could not be set inside the sheath.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.Udi: (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.Device was used for treatment, not diagnosis.Additional h10 narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 CH-24 00; SZ CH-2400
• MDR Report Key: 7606433
• Report Number: 1221934-2018-51904
• Device Sequence Number: 1383518
• Product Code: MBI
• UDI-Device Identifier: 10886705027521
• UDI-Public: 10886705027521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2018

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: 09/30/2020
• Device Catalogue Number: 254825
• Device Lot Number: L544299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 06/25/2018; 11/05/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/16/2018; 11/06/2018; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1