MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR, 0DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	228140
Medical Device Problem Codes	Disconnection (1171); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
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.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that during an unknown procedure the first implant was positioned correctly in the applicator, but when the doctor used the correct technique (using a malleable hemicanuka) after having crossed the meniscus, the implant would not discharge from the gun despite having repeatedly pressing the trigger.The second implant was positioned correctly in the applicator, but when the doctor used the correct technique (using a malleable hemicanuka) after having crossed the meniscus and fired the first implant, when positioning the second implant a few millimeters, every system came out of the applicator.The surgeon did not want to continue hurting the meniscus with meniscal suture and so chose to do a meniscectomy instead.
Additional Manufacturer Narrative
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.H10 additional narrative: investigation summary: the complaint device associated with this complaint was sent to depuy mitek site in (b)(6) on (b)(6)19.The tracking number provided shows it was delivered in (b)(6); however there is no signature of receiving in the complaints group.After repeated attempts to locate the device, it could not be found; therefore, a physical device evaluation cannot be performed.A capa was created to address the systemic issue associated with missing complaint devices at the site and the action was completed on (b)(6)2019.As this complaint falls within this time frame, the corrective action is captured in this capa.If and when the device is located, the complaint will be re-opened to complete the investigation.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: OMNISPAN MENISCAL REPAIR, 0DEG
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8473162
• Report Number: 1221934-2019-56734
• Device Sequence Number: 11222443
• Product Code: MAI
• UDI-Device Identifier: 10886705010028
• UDI-Public: 10886705010028
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 09/30/2020
• Device Model Number: 228140
• Device Catalogue Number: 228140
• Device Lot Number: L603954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1