MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Model Number 314.743

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

Patient Problems No Patient Involvement (2645); Foreign Body In Patient (2687)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro-code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been requested.The investigation could not be completed; 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 Description

It was reported that on (b)(6) 2019, during a femur excision with autograft procedure, the tip of the reamer/ irrigator/ aspirator (ria) drive shaft and the 15.5mm reamer head shattered when making a pass down the canal of the femur.There was one (1) hour surgical delay to bring in another drive shaft and have it sterilized.The reporter commented that one or two little pieces of small metal fragments have remained in the proximal of the femoral canal of the patient.The procedure and patient outcomes are unknown.This complaint involves two (2) devices.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A dhr file could not be reviewed as it has not yet been scanned into tungsten as of dec 04, 2019.Jde confirmed that the lot was released for sale oct 24, 2019 and an etq mdd nonconformance module search confirmed that no ncrs were generated during production.Therefore, it can be determined that there were no issues during the manufacture of the product that 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.

Manufacturer Narrative

Product complaint#: (b)(4).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: investigation summary the complaint is confirmed as we are able to confirm that the reamer head is broken based on the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.H11, h6: method code reported.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.D10 h3, h4, h6: part: 314.743, lot #: h757662, per jde, manufactured date: 05/23/19.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.Visual inspection: the driveshaft minimum 520 mm length for use with ria (p/n: 314.743, lot #: h757662) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the shaft was broken inside the driveshaft helix and the drive shaft helix was cracked and started to peel.The broken part was lodged inside the 15.5 mm reamer head-sterile.The mating device was investigated under a different pi in the same pc.No other issues were identified on the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed drive shaft assembly.Complaint confirmed? yes, the device received was broken but reported pieces of small metal fragments remained in the proximal of the femoral canal of the patient cannot be confirmed with the available information.Investigation conclusion the complaint condition is confirmed for the driveshaft minimum 520 mm length for use with ria (p/n: 314.743, lot #: h757662).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 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: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9439364
• MDR Text Key: 194760865
• Report Number: 2939274-2019-62582
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042
• Combination Product (y/n): N
• PMA/PMN Number: K042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: H757662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 02/21/2020
• Patient Sequence Number: 1
• Patient Weight: 110