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

Catalog Number 03.404.022S

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

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

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code hto.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during an unknown surgery the wings of the ria2 drill bit was break.The surgeon used drill head to complete the procedure.There was fragment generated and the wings of drill head remains in the patient body.The surgery was completed successfully with 10 minutes delay.There were no consequences of the patient.This complaint involves one (1) device.This report is for (1) 13.0mm reamer head for ria 2 sterile.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.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: 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 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.Visual inspection: the reamer head f/ria 2 ø13( p/n: 03.404.022s; lot # 46p3569) was received at us customer quality (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 the broken pieces were not returned.The reported condition of embedded device was not confirmed as there is no evidence of images/x-rays are provided.No other issues were identified with the device.Device failure/ defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: - 14.0mm reamer head ria2.Complaint confirmed? yes; received device was broken.Conclusion: the complaint condition is confirmed for the reamer head f/ria 2 ø13( pp/n: 03.404.022s; lot # 46p3569).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 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.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: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10346264
• MDR Text Key: 201325011
• Report Number: 8030965-2020-05500
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07612334142443
• UDI-Public: (01)07612334142443
• Combination Product (y/n): N
• PMA/PMN Number: K993335
• 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
• Report Date: 07/22/2020

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: 07/30/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/31/2020; 09/11/2020; 09/30/2020
• Supplement Dates FDA Received: 08/31/2020; 09/29/2020; 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR