MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER (309.035)

Model Number	309.038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: investigation flow: damage.Visual inspection: the spare reamer tube for hollow reamer (309.035) (p/n: 309.038, lot number: 1l12134) was received at us cq.Upon visual inspection, a tooth has broken off the tip.There were no x-rays or other photographs provided, so the broken off piece cannot confirmed to be embedded within the patient.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: current and manufactured document was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as one of the teeth has broken off the tip.The tooth cannot be confirmed to have embedded within the patient.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: 309.038 (sub-component 36599).Lot: 1l12134.Manufacturing site: bettlach.Release to warehouse date: october 25, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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 (b)(6) 2020 that during a screw removal time a trephine was broke off.Fragments were generated but it was unknown if it was removed.The procedure was successfully completed.Patient consequence is unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: SPARE REAMER TUBE FOR HOLLOW REAMER (309.035)
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9930244
• Report Number: 2939274-2020-01738
• Device Sequence Number: 2415725
• Product Code: HTO
• UDI-Device Identifier: 10886982185556
• UDI-Public: (01)10886982185556
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 309.038
• Device Catalogue Number: 309.038
• Device Lot Number: 1L12134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention