MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number 352.257S

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

Patient Problems No Patient Involvement (2645); Foreign Body In Patient (2687); Not Applicable (3189)

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 2 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.Device history (lot) part # 352.257s, synthes lot # h602147, supplier lot # na, released to warehouse date: jul 26, 2018, manufactured by synthes monument, expiration date: jun 30, 2027, no ncr's 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.

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, h6: part # 352.257s, synthes lot # h602147, supplier lot # na, released to warehouse date: 26 jul 2018, manufactured by synthes monument, expiration date: 30 jun 2027, no ncr's 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.Visual inspection: the 15.5 mm reamer head sterile for reamer/irrigator/aspirator (p/n:352.257s, lot #: h602147) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the tabs were broken and not returned.The broken fragment of the driveshaft minimum 520 mm length for use with ria (314.743) was received stuck inside the received device.The mating device is being investigated in a different pi under the same pc.No other issues were identified with 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 -15.5 mm reamer head.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 15.5 mm reamer head sterile for reamer/irrigator/aspirator (p/n:352.257s, lot #: h602147).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: 15.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9439374
• MDR Text Key: 194761135
• Report Number: 2939274-2019-62585
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194565
• UDI-Public: (01)10886982194565
• 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: 352.257S
• Device Catalogue Number: 352.257S
• Device Lot Number: H602147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 02/20/2020
• Patient Sequence Number: 1
• Patient Weight: 110