MAUDE Adverse Event Report: DEPUY MITEK LLC US NIT MENSCL SUT NDL W2-0 OC 5PK; POLYDIOXANONE SUTURE

Model Number	228145
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: according to the information provided, it was reported that the orthocord sutures that normally come (3 envelope in total) were not inside, only the nitinol needle.Silver inner package was received without the needle nor the needle package.However, a photo was provided by the customer with the needle package missing the sutures, based on that; the customer complaint was confirmed.A manufacture investigation was performed and its most probable that the customer may have fallen the sutures after the pouch opening.As per pfmea an complaint reviews, the occurrence for this type of issue is below than the maximum occurrence allowed for this kind of effect.Since the needle package was not received for evaluation, we cannot determine a possible root cause for the issue experienced by customer.A manufacturing record evaluation was performed for the finished device [3l87866] number, 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 [3l87866] number, and no non-conformances were identified.
Event or Problem Description
It was reported by the affiliate that during an arthroscopy when the package of the nit menscl sut ndl w2-0 oc 5pk was opened it was noted that the suture that normally come in an envelope, were not inside only the nit menscl sut ndl w2-0 oc 5pk.It was further reported that the package was sealed and not damaged and the security seal was not broken.During in-house engineering evaluation, it was determined that the silver inner package was received without the needle nor the needle package.It was not reported if there was a delay or if a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: NIT MENSCL SUT NDL W2-0 OC 5PK
• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9997494
• Report Number: 1221934-2020-01239
• Device Sequence Number: 3699854
• Product Code: NEW
• UDI-Device Identifier: 10886705010073
• UDI-Public: 10886705010073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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: 02/28/2022
• Device Model Number: 228145
• Device Catalogue Number: 228145
• Device Lot Number: 3L87866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 04/24/2020
• Patient Sequence Number: 1