MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 0 DEGREE PLGA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	228160
Medical Device Problem Code	Failure to Discharge (1169)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
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 sales rep via phone that during a knee arthroscopy the truespan meniscal repair system plga 0 degree misfired.Another device was used to complete the procedure.No patient consequences or surgical delay reported.This device was discarded.
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.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.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number [5l82001], and no non-conformances were identified.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.Device history lot : a manufacturing record evaluation was performed for the finished device lot number [5l82001], and no non-conformances were identified.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: investigation summary : the device was received and inspected.Visual inspection showed that there were no implants were with in sleeve and no damage were observed on the returned device.Functional testing: the trigger was working as intended.The complaint cannot be confirmed for the reported implants misfired/will not release condition since there were no implants were received and no functional issues were noticed to device's trigger.With the information provided, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number [5l82001], and no non-conformances were identified.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: TRUESPAN 0 DEGREE PLGA
• 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: 9553226
• Report Number: 1221934-2020-00041
• Device Sequence Number: 11628501
• Product Code: MBI
• UDI-Device Identifier: 10886705026036
• UDI-Public: 10886705026036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2019

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: 07/31/2022
• Device Model Number: 228160
• Device Catalogue Number: 228160
• Device Lot Number: 5L82001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/30/2020; 08/28/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/31/2020; 08/31/2020
• Patient Sequence Number: 1