MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RIA DRIVESHAFT L520; REAMER

Catalog Number 314.743

Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

Additional pro code: hrx.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.(b)(4).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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for distal tibia fracture with the drive shaft in question.During bone aspiration in femoral diaphyseal bone, when the ria reached subtrochanteric area, it became difficult to ream the bone.The surgeon pushed and pulled the reamer to ream the bone.Then, he found metal-like foreign matters around the reamer head by x-rays.He stopped reaming immediately and tried to remove them.However, 3 or 4 fragments could not be removed and remained in the bone.The surgery was delayed by less than 30 minutes.During the surgery, the locking clip once detached from the device while reaming.No further information is available.Concomitant device reported: unknown reamer irrigator aspirator (ria) tube assembly (part # unknown, lot # unknown, quantity # 1).This complaint involves four (4) devices.This is 1 of 4 for report (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 product investigation was conducted.Visual inspection: the ria driveshaft l520 (p/n: 314:743, lot number: 7061004) was received at us cq.Visual inspection of the complaint device showed the distal end of the driveshaft has broken off.A portion of the missing distal tip can be seen inside the ria reamer head ø12.As that portion is unable to be extracted, it is not able to be determined if there are additional fragments missing.Functional test: a functional test was unable to be performed since the mating devices were not returned.Complaint is confirmed for broken, no for embedded and no for will not seat/advance dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review:no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the ria driveshafts distal end is broken off.The complaints that the ria driveshaft will not seat/advance and that the ria driveshaft is embedded are not confirmed.No definitive root cause could be determined based on the provided information.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 device history record (dhr) review was conducted: part number: 314.743.Synthes lot number: 7061004.Supplier lot number: n/a.Release to warehouse date: 03apr2013.Expiration date: n/a.Supplier: criterion tool & die, inc.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: 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: RIA DRIVESHAFT L520
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9260703
• MDR Text Key: 180719500
• Report Number: 8030965-2019-69862
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739208
• UDI-Public: (01)07611819739208
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.743
• Device Lot Number: 7061004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 11/05/2019; 12/04/2019
• Supplement Dates FDA Received: 11/27/2019; 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - RIA.
• Patient Outcome(s): Required Intervention