MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number 03.404.022S

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

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2020 that during the collection of spongiosa, the reamer head (03.404.022s) detached from the drive shaft for ria2 (03.404.035).After loosening, the slats broke off at the back of the reamer head (03.404.022s).The broken parts were left in the femur, three (3) out of four (4) were retrieved.One (1) broken metal part is still in the femur and could not be removed.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed.Concomitant device: drive shaft for ria 2 (part# 03.404.035, lot# unknown, quantity# 1).This report is for one (1) 13.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).

Event Description

Unknown ria tube assembly (part # unknown, lot # unknown, quantity # 1).

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 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 device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history lot part #: 03.404.022s, synthes lot #: 46p3569, supplier lot #: 46p3569, release to warehouse date: feb 27, 2020, expiration date if required: mar 01, 2030, supplier: (b)(4).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.

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- complaint is confirmed as we are able to confirm complaint description (broken) based on the received pictures.Product was not returned therefore no further investigation possible.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 (information or/and material), the investigation will be updated as applicable.Device history lot part #: 03.404.022s, synthes lot #: 46p3569, supplier lot #: 46p3569, release to warehouse date: 27-feb-2020, expiration date if required: 01-mar-2030, supplier: (b)(4).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

Depuy synthese 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 reamer head f/ria 2 ø13( p/n: 03.404.022s; lot #46p3569) was received at us cq.Upon visual inspection it was noticed that the proximal end of the reamer where it is inserted into the drive shaft has completely broken off and two of the broken piece was not returned.In the x-ray images from attachments it can be found that the broken pieces of the reamer were embedded in the femur bone.The reported condition of fell apart cannot be confirmed as not all the broken pieces and the mating device were returned.No other issues were identified with the device.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 history lot part #: 03.404.022s, synthes lot #: 46p3569, supplier lot #: 46p3569, release to warehouse date: 27-feb-2020, expiration date if required: 01-mar-2030, supplier: (b)(4) ,part #: 03.404.022s.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.,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: 13.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10235651
• MDR Text Key: 198206850
• Report Number: 8030965-2020-04660
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.022S
• Device Lot Number: 46P3569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/18/2020
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT F/RIA 2 L520; UNKNOWN RIA TUBE ASSEMBLY
• Patient Outcome(s): Required Intervention