MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM MEDULLARY REAMER HEAD

Model Number	352.140
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual inspection it was noticed that the cutting edges were found slightly dull.Hence, the complaint is confirmed.Also, there are scratches/nicks.A manufacturing record evaluation was performed for the finished device lot number, the device is 13+ years old and no non-conformances were identified.The complaint is confirmed for dull reported condition.The exact cause of the dull edges is unknown.It is determined that the device is worn from repeated use and servicing therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: lot part: 352.140.Lot: 2157581.Manufacturing site: (b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 an unknown date, during inspection of instruments while putting the set back together, the two (2) medullary reamer head were noticed dull to the touch and appearance.There was no patient involvement.This report is for one (1) 14.0 mm medullary reamer head.This is report 1 of 2 for (b)(4).

• Brand Name: 14.0MM MEDULLARY REAMER HEAD
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8841938
• Report Number: 2939274-2019-59439
• Device Sequence Number: 318418
• Product Code: HTO
• UDI-Device Identifier: 10886982194282
• UDI-Public: (01)10886982194282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 352.140
• Device Catalogue Number: 352.140
• Device Lot Number: 2157581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1