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

Catalog Number 352.085

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

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

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(6).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 synthes reports an event in (b)(6) as follows: it was reported that during a right tibial nailing procedure on (b)(6) 2019, while reaming the tibia shaft, the 8.5 reaming head broke.There was no patient harm reported; however, a piece of the metal reamer metal stainless steel head could not be removed from the patient.Concomitant device reported:unknown shaft (part # unknown, lot # unknown, quantity 1).This report is for one (1) 8.5mm medullary reamer head.This is report 1 of 1 for complaint (b)(4).

Event Description

Further it was reported that the reamer head broke into 3 pieces.Removal of the broken, damaged device or fragments was done, but approximately 20 mins of several attempts, 1 piece could not be removed.A ligature carrier forceps was used to remove 2 broken pieces.The procedure was completed successfully.

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: age; sex; description of event or problem.Patient code 3191 used to capture additional medical/surgical intervention required.Device manufacture date, adverse event problem: a device history record (dhr) review was conducted: part: 352.085, lot: 26947, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: (b)(6) 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrected data: mfr site: physical manufacturer.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.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: 9404223
• MDR Text Key: 185505500
• Report Number: 8030965-2019-70710
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243699
• UDI-Public: (01)07611819243699
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

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: 352.085
• Device Lot Number: 26947
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 12/04/2019; 01/02/2020
• Supplement Dates FDA Received: 12/24/2019; 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - FLEXIBLE SHAFTS
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR