MAUDE Adverse Event Report: DEPUY MITEK LLC US GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM; SCALPEL, SINGLE-USE

Model Number	232110
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.Udi: (b)(4).E3: reporter is a j&j sales representative.H4: the device manufacture 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 or Problem Description
It was reported by the sales rep that upon receipt of the graft instruments acl graft knife 10mm device, it was observed that a hair was found inside its sterile pouch.There was no procedure nor patient involvement reported.No additional information was provided.
Additional 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: 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 a foreign matter appears to be inside of the pouch.With the photo provided is not possible to determine if the pouch was opened.Only a partial part of the device is shown in the photo, no structural anomalies were noted.A manufacturing record evaluation was performed for the finished device 9l90060 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection, this complaint can be confirmed.The manufacturer performed an investigation with the following results: the batchs have been assembled by operators trained and certified on the process validated in production; 100% control according to the procedure wi-emsp072 rev 22 must be performed by the operator during sealing in cleanroom according to the pic-vse0028 and wi-ft 0119.100% control according to the procedure wi-ft 0119 rev 9.100% control according to the procedure wi-ft0281 rev4.100% control according to the procedure pic-vse0028 rev8.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Analysis showed that the production controls implemented guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control, guarantee that the device had not a foreign matter inside the packaging we can conclude that it is highly unlikely that these defects were generated during the manufacturing process.A manufacturing investigation activity was conducted to determine if there were any internal processing issues that may have contributed to the nature of the product complaint.A through review of production process controls was conducted.The results show that this batch of product was processed without incident.Nevertheless, there is no evidence of manufacturing anomalies.1 photo was sent to us for analysis.We cannot see the direction of the product, the end of the handle should be on the chevron side.We cannot see if the product has been opened.Based on the above, it is confirmed that the manufacturing process was performed in accordance with the validated processes.The root cause is not related to manufacturing.This product issue is already being addressed by depuy quality system.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: GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM
• Common Device Name: SCALPEL, SINGLE-USE
• 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: 17193373
• Report Number: 1221934-2023-02509
• Device Sequence Number: 7333549
• Product Code: GDX
• UDI-Device Identifier: 10886705010998
• UDI-Public: 10886705010998
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 232110
• Device Catalogue Number: 232110
• Device Lot Number: 9L90060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown