MAUDE Adverse Event Report: DEPUY MITEK LLC US ACL DRILLPN W/EYE .094X14" *EA; SURGICAL HAND DRILL

Model Number 219321

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported via the affiliate that before an anterior cruciate ligament reconstruction repair on 2 of the acl drillpn w/eye.094x14" ea were mismatching with the labels on the package.No patient consequence, and no surgical delay.No additional information was provided.

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.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: according to the information provided, it was reported that on 2 of the acl drillpn w/eye.094x14" were mismatching with the labels on the package.The complaint device is not being returned, therefore unavailable for a physical evaluation.This issue was reviewed with supplier ¿paragon¿ to identify if this is mislabeling issue, referenced in the (b)(4).As per information provided by supplier, the batch number 1906574, was automatically assigned by sap or manually assigned to all raw materials, sub-assemblies and finished goods.Logistics maintains batch traceability of raw materials, sub-assemblies and finished goods through labeling or other appropriate methods.This applies to the handling, storage, quarantine and distribution of materials.The lot 1906574 is corresponding for finished goods (this was the 74th order packaged in our non-sterile packaging area in june 2019).Since the labels and the laser marks on the devices are correct and traceable.We cannot confirm the customer complaint.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), 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/serial number (b)(6), and no non-conformances were identified.

• Type of Device: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9771472
• MDR Text Key: 206174038
• Report Number: 1221934-2020-00709
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705005727
• UDI-Public: 10886705005727
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 219321
• Device Catalogue Number: 219321
• Device Lot Number: 1906574
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2020
• Patient Sequence Number: 1