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

Model Number	228160
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(6).The expiration date is currently unavailable.Patient identifier: (b)(6).Investigation summary: according to the information provided, it was reported that during a meniscal repair, the needle broke when sliding gun into the knee.In the second gun, the implant did not reach past the capsule and had to be cut out.The complaint devices were discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint devices were discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [6l84375] number, and no non-conformances related to the reported complaint condition 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.
Event or Problem Description
It was reported by the sales rep that during a meniscal repair procedure on (b)(6) 2021, it was observed that the truespan 0 degree plga device did not reach past the capsule and had to be cut out.Another like device was used to complete the procedure with a seven minute delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: TRUESPAN 0 DEGREE PLGA
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11333870
• Report Number: 1221934-2021-00529
• Device Sequence Number: 883917
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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 Model Number: 228160
• Device Catalogue Number: 228160
• Device Lot Number: 6L84375
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1