MAUDE Adverse Event Report: SYNTHES GMBH SYNREAM REAMING ROD 2.5 LONG L1150; REAMER

Catalog Number 352.033

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes (b)(6) reports an event as follows: it was reported the reaming rod was bent and the drill did not pass.The surgeon broke the device but was able to use it to complete the procedure.The procedure was successfully completed with a twenty (20) minute delay and no medical intervention needed.This report is for a reaming rod.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, h4, h6- the device was not returned for investigation.- formato novedad clínica ibagué stock¿ under the attachment section.Upon analysis of the image, the reaming rod was bent and broken during surgery.The potential cause for the bending could be an un intended excessive force applied during surgery.The rods were broken into two by the surgeon as mentioned in the additional information received from the employee hence this could not be attributed to the device.A definitive assignable root cause could not be determined from the available information.A manufacturing record evaluation could not be performed as no lot number information was available.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.The complaint condition can be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Dhr review was not performed due to the lack of lot number information.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.H3, h6: the lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the synream reaming rod ø2.5 long l1150 (p/n: 352.033, lot #: unk) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was bent.No broken features were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: the thickness of the rod was measured to be within the specification.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawings was reviewed.Reaming rod / bohrdorn ø2.5mm.Complaint confirmed? yes, the device received was bent.Investigation conclusion: the complaint condition was confirmed as the device was bent.However, the broken condition could not be confirmed.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: SYNREAM REAMING ROD 2.5 LONG L1150
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12246695
• MDR Text Key: 264293043
• Report Number: 8030965-2021-06228
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819287525
• UDI-Public: (01)07611819287525
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNREAM REAMING ROD Ø2.5 SHORT L950