MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INTRAFIX ADV PEEK SCW 9X30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254822
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Tissue Damage (2104)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the sales rep via phone that post to an acl reconstruction procedure done in (b)(6) of 2018, the sales rep's peek intrafix advance screw 9x30mm and peek intrafix advance large sheath 30mm migrated inside the patient's joint space and the proximal end of the screw was sticking out of the bone hole.The screw and sheath were removed on (b)(6) 2018.The sales rep stated the surgeon used a probe to remove the sheath and screw, and no other implants were implanted.The sales rep was not present for the case and could not provide any additional information.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement.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 will be submitted accordingly.
Event or Problem Description
Additional information received on 05october2018: the patient was experiencing stiffness following the first procedure in (b)(6).
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.Evaluation statement: the complaint screw and sheath were received and evaluated.Visual inspection reveals the screw is fully seated inside the sheath and there is tissue and blood debris on both the devices indicating the screw and sheath were implanted.There are no structural anomalies on the screw surface when observed under magnification.The sheath is separated and has striations on the distal tip, but as expected for a sheath that was implanted.Possible root causes for the reported failure are tunnel size may not be appropriate for the screw/ sheath implanted or the bone quality of the patient may be soft but no further procedure details were provided to determine a root cause for the reported failure.A non-conformance search was performed for this part (254822), lot (l356594) combination and no non-conformance's were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.(b)(4).Associated medwatch report number: 1221934-2018-54840.

• Brand Name: INTRAFIX ADV PEEK SCW 9X30MM
• 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: 7939855
• Report Number: 1221934-2018-54839
• Device Sequence Number: 2255429
• Product Code: MBI
• UDI-Device Identifier: 10886705027484
• UDI-Public: 10886705027484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 254822
• Device Lot Number: L356594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANCHOR DEVICES
• Outcome Attributed to Adverse Event: Other