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 Injury (2348); Foreign Body In Patient (2687)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 australia reports an event as follows: it was reported that on (b)(6) 2020 that the bone was measured at around 12mm at the ishamus.A 13mm reamer head size was chosen.The ria 2 was put together as per the surgical technique.The im canal was opened with an opening reamer from the ria 2 set and the 2.5mm guide wire was put down the left femur.The ria 2 system was used on drill speed as per the surgical technique.It was noted that the patient had harder bone than expected.The reamer reached the end of the femur and some metal shards were identified.The ria 2 system was removed and an attempt was made to remove the metal shafts using an endoscopic grasper.This was unsuccessful.Concomitant devices reported: guide wire (part # 357.399s, lot # 6l64784, quantity # 2) synream reaming rod (part # 352.032s, lot #7l07367 , quantity # 1) variable angle medial distal tibia plate (part # 02.118.007s, lot # l356385 , quantity # 1).This report is for one (1) 13.0mm reamer head for ria 2 sterile.This is report 1 of 3 for (b)(4).

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, h4, h6: 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).Device history batch, null device history review 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.H3, h6: investigation summary: background: ria 2 case - bone was measured at around 12mm at the ishamus.A 13mm reamer head size was chosen.Ria 2 was put together as per the surgical technique from what was witnessed.Surgeon (b)(6) opened the im canal with an opening reamer from the ria 2 set and put the 2.5mm guide wire down the left femur.From there the ria 2 system was used on drill speed as per the surg tech.It was noted that the patient had harder bone than expected.Reamer reached the end of the femur and some metal shards were identified.Ria 2 system was removed and an attempt was made to remove the metal shafts using an endoscopic grasper.This was unsuccessful.Reamer head and shaft/tube are available to be sent back.09/30/2020: concomitant devices reported: guide wire (part # 357.399s, lot # 6l64784, quantity # 2), synream reaming rod (part # 352.032s, lot #7l07367 , quantity # 1), variable angle medial distal tibia plate (part # 02.118.007s, lot # l356385 , quantity # 1).Not: the following investigation is based on the device received and pictures attached.Investigation flow: damage.Visual inspection: reamer head f/ria 2 ø13 (part# 03.404.022s, lot# 46p3569, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the proximal tabs of the reamer head were broken.A white colored material like bone cement was observed inside the reamer head.Broken fragments were not returned at cq and observed embedded in the patient body in the provided x-ray.Thus, the complaint is being confirmed.Device failure/ defect was identified.Dimensional inspection: dimensional inspection of the received device was not performed due to post manufacturing damage.Document/ specification review: the following drawings were reviewed during the investigation: -14.0mm reamer head ria2: 03_404_024 rev.A.No design issues or discrepancies were noted during the investigation.Complaint was confirmed.Investigation conclusion: the complaint is being confirmed for reamer head f/ria 2 ø13 (part# 03.404.022s, lot# 46p3569) as the device was found to be broken.While a definitive root cause cannot be determined for the reported problem, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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: 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: 10692318
• MDR Text Key: 215897622
• Report Number: 8030965-2020-08022
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Report Date: 09/23/2020

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: 03.404.022S
• Device Lot Number: 46P3569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/12/2020
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT F/RIA 2 L520; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; GUIDEWIRE Ø3.2 L400; REAMER HEAD F/RIA 2 Ø13; RIA 2 BONE HARVESTING KIT L520; SYNREAM REAMING ROD Ø2.5 SHORT L950; SYNREAM REAMING ROD Ø2.5 SHORT L950; VA-LCP MED DIST TIB PL 2.7/3.5 LE 8HO L1; VA-LCP MED DIST TIB PL 2.7/3.5 LE 8HO L1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR