MAUDE Adverse Event Report: DEPUY MITEK LLC US DEPLOYMENT GUN; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number 214710

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: udi: (b)(4).D4: the expiration date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by a healthcare professional in china that preoperatively to an unknown procedure on (b)(6) 2023.It was observed that the lot number printed on the outside packaging of the deployment gun device did not match the lot number printed on the actual device itself.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the lot number etched on the device's shaft is different from the device's package label.An investigation with the manufacturer was performed with the following result: for j&j product, we follow j&j procedure mps-203000.In that procedure i will identify two separate sections.Section 6.3.2 describes the requirements for a date code to be placed on the part.Section 7.1 gives insight to the requirements for raw materials, sub-assemblies, and finished goods.These two coding systems have been in place in the smithfield facility for the 17 years we have been paragon medical.It was adopted as part of the purchase of this facility from depuy mitek who used this system in this facility prior to 2006.In short this is the lot coding and fished goods coding for most if not all product sent to the bridgewater facility, and is completed in this fashion.For part number 214710 (assembly level part code 108729) : (production lot coding i.E.¿ 2107001).Section 6.3.2 lot numbers.When required by engineering drawings, the lot number is to be etched in the following format: date for manufacturing is to be shown as 2 digits each for the year and month.A leading "0" is to be placed in front of all single digit month designations (e.G., september is 09).A sequential three-digit lot number, beginning with 001 and incremented by 1 for each lot, indicates the count of lot manufactured on that month.Placeholder zeros are used to fill blanks, examples ¿001¿,¿008, ¿053¿.The full lot number required for products is therefore shown (by example,yymm) as follows: 0709006 where: 07 is the year of manufacture (2007) 09 is the month of manufacture (september) 006 is the 6th lot manufactured on this month.Month of manufacture shall be when the parts are marked.This should occur as close to the end of the work order as possible, to reflect the completion of manufacturing process.Section 7.1 responsibilities (logistics lot coding i.E.¿ 2109509) 7.1.1 batch numbers will be automatically assigned by sap or manually assigned to all raw materials, sub-assemblies and finished goods.7.1.2 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.In regard to section 7.1 where sap does not issue a finished goods number, paragon manually generates and uses a year year month month 5xx code to identify j&j bridgewater product.I want to reiterate again that this process was adopted from depuy¿s method and has remained unchanged.It is the assertion of paragon medical that the described issue is not a deficiency.The lot coding on the part and the finished goods number identified on the label are as intended and are both capable of identifying and allowing a detailed review of the dhr¿s associated with this complex assembly.Based on the investigation findings, the reported complaint was not confirmed.A manufacturing record evaluation was performed for the finished device 2109509, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17162791
• MDR Text Key: 317873381
• Report Number: 1221934-2023-02474
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705004416
• UDI-Public: 10886705004416
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214710
• Device Catalogue Number: 214710
• Device Lot Number: 2109509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1