MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PW PIN PULLER; EXTRACTION INSTRUMENTS

Catalog Number	966515
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H6: photo investigation: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that '966515, pw pin puller¿ had foreign substance and rust on the surface.Foreign substance and rust found on the device likely due to improper cleaning/ sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the pw pin puller would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to improper maintenance and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
It was reported that during loan kit inspection, by the loan kit technician it was identified that the device is rusty.There is no surgeon, procedure, or patient details available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "rusty." the product was not returned to medtech orthopaedics; however, photos were provided for review.¿image0.Jpeg¿, ¿image1.Jpeg¿, ¿image2.Jpeg¿ and ¿image3.Jpeg¿.The photo investigation revealed that '966515, pw pin puller¿ had foreign substance and rust on the surface.Foreign substance and rust found on the device likely due to improper cleaning/ sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the pw pin puller would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to improper maintenance and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: rusty.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the pw pin puller has sings of foreign matter what appears to be corrosion at the handle.Where corrosion/oxidation was identified around the surface of the device, alongside damage consistent with normal wear, this suggests that the passive layer of the metal has been worn down from repeated use (due to normal use damage) allowing for the metallic surface underneath to become susceptible to corrosion/oxidation.The lifecycle requirements of the device are event related and depend on the use in clinical practice, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of pw pin puller would have contributed to a device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (j0411) provided is not a valid finished goods lot#.H11 additional narrative: corrected: h3.

• Brand Name: PW PIN PULLER
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20323447
• Report Number: 1818910-2024-20353
• Device Sequence Number: 7782622
• Product Code: HWB
• UDI-Device Identifier: 10603295248637
• UDI-Public: (01)10603295248637(10)J0411
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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 Catalogue Number: 966515
• Device Lot Number: J0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 01/23/2025; 01/23/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/31/2024; 01/24/2025; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown