MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 17.0MM REAMER HEAD-STERILE F/REAMER/IRRIGATOR/ASPIRATOR

Model Number	352.261S
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code hrx.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2018, the patient underwent an unknown procedure.During the procedure, the surgeon was pushing down extremely hard on the reamer/irrigator/aspirator (ria).When she went to remove the reamer/irrigator/aspirator (ria) from the patient, they noticed a small portion of the ria head broke off.The broken fragment was left in the patient and they could not remove it.No additional medical intervention was performed.There was a 35-minute surgical delay but it was completed successfully.Patient outcome was reported as healthy.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional information provided.Part: 352.261s; synthes lot: 7022790; supplier lot: n/a; release to warehouse date: (b)(6) 2012; expiration date: july 31, 2021; manufactured by (b)(4).No nonconformance reports (ncrs) were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Product was not returned.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.

• Brand Name: 17.0MM REAMER HEAD-STERILE F/REAMER/IRRIGATOR/ASPIRATOR
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7915621
• Report Number: 2939274-2018-53973
• Device Sequence Number: 1665290
• Product Code: HTO
• UDI-Device Identifier: 10886982194633
• UDI-Public: (01)10886982194633
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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 Expiration Date: 07/31/2021
• Device Model Number: 352.261S
• Device Catalogue Number: 352.261S
• Device Lot Number: 7022790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Weight: 74