MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10.0MM MEDULLARY REAMER HEAD

Catalog Number 352.1

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

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 flexible reamers were used to widen the isthmus of a canal during a revision of a cemented hip stem.The cement had been removed prior to the surgeon attempting to widen the narrow isthmus for the long revision stem.The guide rod was used to ream the canal, but when the flexible shaft was removed, the reamer head was not on it.The surgeon attempted to retrieve the reamer head, but decided to leave it in situ.The procedure was completed successfully.This report is for one (1) 10.0mm medullary reamer head.This is report 1 of 3 for (b)(4).

• Brand Name: 10.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10785358
• MDR Text Key: 214570443
• Report Number: 8030965-2020-08551
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243729
• UDI-Public: (01)07611819243729
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• 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: SYNREAM FLEXSHAFT; SYNREAM FLEXSHAFT; SYNREAM REAMING ROD Ø2.5 SHORT L950
• Patient Outcome(s): Required Intervention