MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8.5MM MEDULLARY REAMER HEAD

Model Number 352.085

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 while using the 8.5mm medullary reamer head in the medullary canal a fragment broke off inside the patient's bone.The surgery continued without trying to extract this fragment because it was very small and does not represent harm to the patient.The procedure was completed successfully without delay.Concomitant device: unknown flexible shaft (part # unknown, lot # unknown, quantity 1).Unknown reaming rod (part # unknown, lot # unknown, quantity 1).This report is for one (1) 8.5mm medullary reamer head.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.Additional narrative: updated data: event.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

The fragment was not and will not be removed; the fragment remained in the medullary canal of the patient's tibia and away from the joint.

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.The synream reamer head 8.5 (p/n (b)(4), lot number 15932) was received at us cq.Visual inspection of the complaint device showed one of the flutes had a chip that had broken off.The reamer head blades were dull, and the tip of the device was deformed.The reamer head blades were felt and determined to be dull; the broken off fragment could not be determined to be embedded in the patient (no images provided), thus the embedded device complaint is not confirmed.This complaint is confirmed as one of the flutes had a chip that had broken off, the reamer head blades were dull, and the tip of the device was deformed.No definitive root cause could be determined based on the provided information.The embedded device allegation could not be confirmed as no images were provided.No new, unique or different patient harms were identified as a result of this evaluation.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 8.5MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9354184
• MDR Text Key: 185209587
• Report Number: 8030965-2019-70470
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194176
• UDI-Public: (01)10886982194176
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.085
• Device Catalogue Number: 352.085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - FLEXIBLE SHAFTS; UNK - REAMING RODS
• Patient Outcome(s): Required Intervention