MAUDE Adverse Event Report: 13.0MM MEDULLARY REAMER HEAD

Model Number	352.130
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
It was reported that on (b)(6) 2021, during field inventory, there were (14) reamer heads that were dull.There was no patient involvement.This report is for (1) 13.0mm medullary reamer head.This is report 11 of 14 for (b)(4).
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.Investigation summary visual inspection: the 13.0mm medullary reamer head (p/n: 352.130, lot # pe04834) was returned and received at us cq.Upon visual inspection it was observed that the reamer head blades were dull.No other issues were identified with the returned device.Device failure/defect identified? yes functional test: the functional test was not performed as the device was received by itself.However, the alleged dull/will not cut condition can be confirmed as the received condition of the complaint device was felt and determined to be dull.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Can the complaint be replicated with the returned device(s)? unable to perform complaint confirmed? yes investigation conclusion the complaint condition is confirmed for the 13.0mm medullary reamer head (p/n: 352.130, lot # pe04834).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot product #: 352.130 synthes lot #: pe04834 supplier lot #: pe04834 release to warehouse date: 14 may 2021 supplier: precision edge surgical product no ncrs were generated during production.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 13.0MM MEDULLARY REAMER HEAD
• Common Device Name: REAMER
• MDR Report Key: 12665406
• Report Number: 2939274-2021-06188
• Device Sequence Number: 19953098
• Product Code: HTO
• UDI-Device Identifier: 10886982194268
• UDI-Public: 10886982194268
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 352.130
• Device Catalogue Number: 352.130
• Device Lot Number: PE04834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10.0MM MEDULLARY REAMER HEAD; 10.5MM MEDULLARY REAMER HEAD; 11.0MM MEDULLARY REAMER HEAD; 11.5MM MEDULLARY REAMER HEAD; 12.0MM MEDULLARY REAMER HEAD; 12.5MM MEDULLARY REAMER HEAD; 13.0MM MEDULLARY REAMER HEAD; 13.5MM MEDULLARY REAMER HEAD; 14.0MM MEDULLARY REAMER HEAD; 14.5MM MEDULLARY REAMER HEAD; 8.5MM MEDULLARY REAMER HEAD; 9.0MM MEDULLARY REAMER HEAD; 9.5MM MEDULLARY REAMER HEAD; 10.0MM MEDULLARY REAMER HEAD; 10.5MM MEDULLARY REAMER HEAD; 11.0MM MEDULLARY REAMER HEAD; 11.5MM MEDULLARY REAMER HEAD; 12.0MM MEDULLARY REAMER HEAD; 12.5MM MEDULLARY REAMER HEAD; 13.0MM MEDULLARY REAMER HEAD; 13.5MM MEDULLARY REAMER HEAD; 14.0MM MEDULLARY REAMER HEAD; 14.5MM MEDULLARY REAMER HEAD; 8.5MM MEDULLARY REAMER HEAD; 9.0MM MEDULLARY REAMER HEAD; 9.5MM MEDULLARY REAMER HEAD