MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SHAFT FOR RIA 2 520MM ACCESSORIES, ARTHROSCOPIC

Model Number 03.404.035

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

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Additional product code: hto. Reporter is a j&j representative. Investigation summary investigation flow: device interaction/functional & damage visual inspection: the drive shaft for ria 2 520mm (p/n: 03. 404. 035, lot number: j000427) was received at us cq. Visual inspection of the complaint device showed outer part of the distal tip was deformed, which could not have contributed to the complaint condition. No other issues were identified with the complaint device. The provided photograph was reviewed, and no additional issues were observed. Functional test: a functional assessment was not performed on the complaint device since the device was returned by itself without the reamer head. However, the deformed condition of the complaint device could not cause the complaint condition. The complaint unable to perform with the returned device(s). Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage. Document/specification review: no design issues or discrepancies were identified. Complaint was not confirmed. Investigation conclusion: this complaint was not confirmed as outer part of the distal tip was deformed and could not contribute to the complaint condition. No definitive root cause could be determined based on the provided information. There was no indication that a design or manufacturing issue contributed to the complaint. 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 # 03. 404. 035. Synthes lot # j000427. Supplier lot # j000427. Release to warehouse date: aug 11, 2020. Supplier: mark two engineering inc. No ncr's 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.

Event Description

It was reported that on (b)(6) 2021, the underwent for a surgery. During the surgery, the inner spines of the drive shaft that connect the unknown reamer heads onto the drive shaft stripped out, causing the tines on the unknown reamer heads to break off inside the patient. There was one tine left in the patient. Fragments were generated. There were a 30minutes surgical delay. The procedure successfully completed. No patient consequence. This complaint involves (2) devices. This report is for (1) drive shaft for ria 2 520mm. This report is 1 of 2 for (b)(4).

• Brand Name: DRIVE SHAFT FOR RIA 2 520MM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 12325192
• MDR Text Key: 266695844
• Report Number: 2939274-2021-04682
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982274243
• UDI-Public: (01)10886982274243
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.404.035
• Device Catalogue Number: 03.404.035
• Device Lot Number: J000427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/16/2021 Patient Sequence Number: 1

Treatment

UNK - REAMERS: REAMER HEAD