MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE

Model Number 03.404.018S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4). Additional narrative: additional pro-code: hto. Complainant device is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested and is currently pending completion. 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 Description

It was reported that on an unknown date, during removal the reamer irrigator aspirator (ria) 2 reamer head broke off during reaming. The reamer was removed and fragments not retrievable. It was unknown if there was a surgical delay. The procedure was successfully completed. Patient outcome was unknown. This (b)(4) captures the intra-op event during removal, the reamer head broke off. (b)(4) captures the postop event, removal due to nonunion. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).

• Brand Name: 11.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ARTHROSCOPE
• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11798039
• MDR Text Key: 249730334
• Report Number: 2939274-2021-02276
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273963
• UDI-Public: (01)10886982273963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.404.018S
• Device Catalogue Number: 03.404.018S
• Device Lot Number: 70P1935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unkown
• Removal/Correction Number: Z-0573-2021

Patient Treatment Data

Date Received: 05/10/2021 Patient Sequence Number: 1