MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number 03.404.018S

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 patient underwent an orthopedic procedure.The surgeon performed a bone graft harvest from the left femur to bone graft a left humeral shaft non-union.The surgeon removed a 12 hole 4.5 lc-dcp broad plate and twelve (12) cortex screws from the non-union site and then used the ria 2 system on the left femur to harvest bone graft.A reamer head for reamer irrigator aspirator (ria 2) was selected based on the measurement of the patient's femoral shaft.The surgeon entered the reamer head into the femoral canal and resistance occurred in the proximal third femoral canal.The surgeon retracted the reamer head and then advanced it several times and on the last retraction noticed the reamer head had come off of the drive shaft for reamer irrigator aspirator (ria 2).The doctor was able to retrieve the reamer head and noticed that three fragments from the reamer head had broken off.The surgeon was able to retrieve two of the fragments, but one fragment remained in the soft tissue.Once the two fragments were removed he used the ria system with a 12mm head to complete the bone harvest.The surgeon then implanted a 12 hole 4.5 lcp broad plate and the harvested bone graft to the humerus.The drive shaft was difficult to remove from the tube assembly after the ria 2 was used.The reaming rod seal was noticed to be cracked.The procedure was successfully completed with a sixty (60) minute surgical delay.There was patient consequence.This report is for one (1) 11.0mm reamer head for ria 2 sterile.This is report 1 of 1 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.H3, h6: part#: 03.404.018s, synthes lot number: 43p7412, supplier lot number: 43p7412, release to warehouse date: 12-feb-2020, expiration date: 31-jan-2030, supplier: jabil-monument.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d8.H6.H11 corrected data: d4.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: 11.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10189989
• MDR Text Key: 196416610
• Report Number: 2939274-2020-02968
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273963
• UDI-Public: 10886982273963
• 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,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.018S
• Device Catalogue Number: 03.404.018S
• Device Lot Number: 43P7412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR