MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 13.0MM MEDULLARY REAMER HEAD

Catalog Number 352.13

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

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review / investigation.Reporter is a j&j employee.(b)(4).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.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) 2020, the patient underwent the surgery for femoral trochanteric fractures by using the tfna implants.During the surgery, the surgeon, the surgeon tried to pass the flexible shaft-connected reamer head through 2.5mm reamer rod with extension of 900mm, but he was unsuccessful.While checking the reamer, he inserted the flexible shaft-connected reamer head without the 2.5mm reamer rod with extension of 900mm.As a result, the reamer head came off the flexible shaft, because the connection between the flexible shaft and the reamer head was disconnected in the intrathecal space.He attempted to reconnect the flexible shaft, or remove the reamer head with a guide rod by hooking it, or push up the upper condyle with a k-wire, but he failed.The surgeon inserted the nail while the reamer head was left in the patient¿s body.The surgeon was completed with a less than 30 minute delay.No further information is available.Concomitant device reported: unknown flexible shaft (part # unknown, lot # unknown, quantity # 1); unknown reaming rod (part # unknown, lot # unknown, quantity # 1); unknown k-wire (part # unknown, lot # unknown, quantity # 1).This report is for one (1) 13.0mm medullary reamer head.This is report 1 of 3 for (b)(4).

• Brand Name: 13.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10360263
• MDR Text Key: 201604371
• Report Number: 8030965-2020-05583
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243781
• UDI-Public: (01)07611819243781
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - FLEXIBLE SHAFTS; UNK - GUIDE/ COMPRESSION/ K-WIRES; UNK - REAMING RODS
• Patient Outcome(s): Required Intervention