MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRAFX ADVBR SCW 8X23W/SMSHTH; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	254801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Not Applicable (3189)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4)-incomplete.The exp date is currently unavailable.Patient identified: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 surgeon that the tibial intrafix adv implant device will be removed due to an abscess after the initial acl reconstruction.It was further reported that hardware removal surgery has already been scheduled while the revision surgery will be done at a later date.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement reported.There were no reports of prolonged hospitalization.The patient's status post-surgery was not provided.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Date of event: the date of event was reported as (b)(6) 2018 in the initial report.It has been updated as (b)(6) 2018.The patient identified was reported as unknown in the initial report and has been updated as mrn: (b)(6).The exp date was reported as unknown in the initial report and has been updated as 3/31/2021.Therefore, udi: (b)(4).Investigation summary: the complaint device is not being returned, it was left implanted in the patient, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this part (254801) and lot (l838453) combination and no non-conformances were identified.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.

• Brand Name: INTRAFX ADVBR SCW 8X23W/SMSHTH
• 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: 7942430
• Report Number: 1221934-2018-54847
• Device Sequence Number: 19248692
• Product Code: MAI
• UDI-Device Identifier: 10886705026661
• UDI-Public: 10886705026661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 254801
• Device Lot Number: L838453
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 14 YR