MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number 03.404.016S

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

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: hrx.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that on (b)(6) 2020, the ria2 reamer head 10mm broke at fin junction when reaming the isthmus of tibia.The ria assembly was removed and reamer head fragment remained inside tibia.The surgeon proceeded with a fresh ria2 reamer head 10mm which broke again, the ria assembly was removed and the second reamer head fragment remained inside tibiaa and the surgery continued using the zimmer flexible reamers, starting with 6mm and ending at 11.5mm.The cause for reamer breakage was suspected to be too aggressive forward movement of ria assembly, without a sufficient back movement technique.The surgery was completed as planned with reamer head fragment remaining in tibia.Fragments were retained, the bulk of reamer head was removed but, three pieces remained.There was a twenty (20) to thirty (30) minute surgical delay.The procedure was successfully completed.Concomitant device reported: 10.0mm reamer head for ria 2 sterile (part number 03.404.016s, lot 58p1754, quantity 1).This report involves one (1) 10.0mm reamer head for ria 2 sterile.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: part: 03.404.016s, synthes lot: 58p1754, supplier lot: 58p1754, expiration date: april 30, 2030, release to warehouse date: may 26, 2020, supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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.The instrument(s) was not returned and instead the investigation will be done based on the received image(s).The image(s) was reviewed and the complaint condition could be confirmed as the image provided shows a broken reamer head and x-ray confirms the fragment in the patient.As the instrument(s) was not returned, an as received condition, dimensional inspection, material, or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10566277
• MDR Text Key: 207925838
• Report Number: 2939274-2020-04236
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 58P1754
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10.0MM REAMER HEAD FOR RIA 2 STERILE; 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR