MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.5MM MEDULLARY REAMER HEAD

Model Number	352.135
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
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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) fourteen reamer heads that were dull.There was no patient involvement.This report is for one (1) 13.0mm medullary reamer head.This is report 11 of 14 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.H10 additional narrative: h3, h6: investigation summary investigation flow: functional/device interaction visual inspection: the 13.5mm medullary reamer head (p/n: 352.135, lot # 14842) 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 was identified and the complaint was confirmed.The complaint can not be replicated with the returned device(s).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.Investigation conclusion the complaint condition is confirmed for the 13.5mm medullary reamer head (p/n: 352.135, lot # 14842).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 part # 352.135 synthes lot # xx14842 supplier lot # xx14842 release to warehouse date: 12 aug2009 supplier: synthes gmbh no ncrs were generated during production.Device history 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: 13.5MM MEDULLARY REAMER HEAD
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12667408
• Report Number: 2939274-2021-06215
• Device Sequence Number: 4480070
• Product Code: HTO
• UDI-Device Identifier: 10886982194275
• UDI-Public: 10886982194275
• 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: 352.135
• Device Catalogue Number: 352.135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2009
• 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; 13.0MM 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
• Patient Sex: Unknown