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

Catalog Number	352.13
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10360263
• Report Number: 8030965-2020-05583
• Device Sequence Number: 971701
• Product Code: HTO
• UDI-Device Identifier: 07611819243781
• UDI-Public: (01)07611819243781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 352.13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - FLEXIBLE SHAFTS; UNK - GUIDE/ COMPRESSION/ K-WIRES; UNK - REAMING RODS
• Outcome Attributed to Adverse Event: Required Intervention