MAUDE Adverse Event Report: DEPUY MITEK LLC US CHIA PERCPASSER SUTURE PASSER 5 PACK; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	214101
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A non-conformance search was performed and no non-conformances were identified for the part/lot number combination.
Event or Problem Description
It was reported by the affiliate in (b)(4) that prior to an unknown procedure the device's packaging was not sealed on one side, making it non-sterile.The other devices in the box were properly sealed.The affiliate reported no patient consequence.It was not reported if there was a delay in the surgery or if a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: 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 there was not a significant surgical delay.The procedure was completed with alternates that were readily available as the other packages in the box were sealed.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.No nonconformances were identified for this part-lot number combination per qlik query executed 04/12/2019.The complaint device was received and inspected.The complaint can be confirmed.It was observed that the mitek produced seal was created overlapping the pouch manufacturer's chevron seal, which is the incorrect side of the pouch that should be sealed.A manufacturing investigation was initiated to provide further insight into this failure.A complaint review was conducted for all complaints received over the past 2 years, and only one other complaint was found alleging that the packaging was not sealed.The root cause is most likely attributable to human error and lack of attention during the seal inspection step, relevant actions have been taken to address the issue.At this point, 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 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.

• Brand Name: CHIA PERCPASSER SUTURE PASSER 5 PACK
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8302028
• Report Number: 1221934-2019-56317
• Device Sequence Number: 13865492
• Product Code: LXH
• UDI-Device Identifier: 10886705003433
• UDI-Public: 10886705003433
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2019

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: 10/31/2023
• Device Catalogue Number: 214101
• Device Lot Number: 1L85541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 04/16/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/11/2019; 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1