MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.5 REAMR HD-S REAMR/IRRIGATR/ASPIRATOR; REAMER

Model Number	352.255S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional product code: hrx.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for ankle reconstruction surgery.During the surgery, it was found that the reamer head had sheered off at the connection to the drive shaft and ria tube assembly.The reamer head was retained inside the femur.The plastic tubing on the ria tube assembly was also found to be distorted and ruptured.The ria drive shaft cannot be disconnected from the tube assembly.All fragments that the surgeon was able to extract from the femur were extracted.There are unknown visible artifacts on the x-ray.The surgery was completed successfully with 15-minutes delay.The patient outcome was unknown.Concomitant device reported.Unknown rod (part# unknown, lot# unknown, qty 2); unknown set screw (part# unknown, lot# unknown, qty 6).This complaint involves one (1) device.This report is for (1) 14.5 reamr hd-s reamr/irrigatr/aspirator.This is report 2 of 2 for (b)(4).
Additional 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 - codes updated to imdrf codes.Investigation summary: the complaint device 14.5 reamr hd-s reamr/irrigatr/aspirator (product code: 352.255s, lot number: 9978762) was not received for investigation.A photo investigation was performed based on the images/x-ray attached in the notes & the photographic evidence was reviewed.It can be observed the reamer head as broken.The connection to the shaft was sheared off from the helix cutting block.However, cause for this breakage can not be determined by the photographic evidence, and no further analysis can be performed without physical product.A functional test can not be assessed since part was not returned.Also, it was attached a x-ray in which it was observed fragments of the device embedded to patient.A definitive assignable root cause could not be determined based on the provided information.A manufacturing record evaluation cannot be performed due lot number being unknown.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.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.Device history lot - no ncrs were generated during production.Device history review - 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.
Additional 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, h4, h6- the complaint device 14.5 reamr hd-s reamr/irrigatr/aspirator (product code: 352.255s, lot number: 9978762) was not received for investigation.A photo investigation was performed the connection to the shaft was sheared off from the helix cutting block.However, cause for this breakage can not be determinated by the photographic evidence, and no further analysis can be performed without physical product.A functional test can not be assessed since part was not returned.Also, it was attached a xray in which it was observed fragments of the device embedded to patient.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.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.Device history lot =part # 352.255s , synthes lot # 9978762 , supplier lot # n/a , release to warehouse date: 12 jan2016, manufactured by: synthes monument.No ncrs were generated during production.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.

• Brand Name: 14.5 REAMR HD-S REAMR/IRRIGATR/ASPIRATOR
• Common Device Name: REAMER
• 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: 12876126
• Report Number: 2939274-2021-06829
• Device Sequence Number: 14561624
• Product Code: HTO
• UDI-Device Identifier: 10886982194527
• UDI-Public: (01)10886982194527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2021

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 Model Number: 352.255S
• Device Catalogue Number: 352.255S
• Device Lot Number: 9978762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 01/31/2022
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 01/04/2022; 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 REAMING ROD BALL TIP/950-STERILE; DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA; DRIVE SHAFT SEAL-STERILE FOR RIA-2PK; GRAFT FILTER FOR RIA-STERILE; RIA TUBE ASSEMBLY MIN 520 LNTH-S 314.743
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown