MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNREAM REAMER HEAD Ø12

Catalog Number 352.120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.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 the (b)(6) as follows: it was reported that on (b)(6) 2019 that a consultant surgeon was using the synream instrument system with a 12mm reamer head on the reamer shaft, he was reaming the femoral canal over the synream 950mm reaming rod.Distally, the reamer head became dislodged off the reamer shaft and when the surgeon removed the synream rod, it left the reamer head behind.There was no damage to the 12mm reamer head of the synream instruments.The correct reaming rod was also in use.This delayed the surgery by approximately 1 hour.Concomitant device reported: unknown reaming rod (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) synream reamer head ø12.This is 1 of 2 for report (b)(4).

• Brand Name: SYNREAM REAMER HEAD Ø12
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9241386
• MDR Text Key: 194301788
• Report Number: 8030965-2019-69708
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243767
• UDI-Public: (01)07611819243767
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• 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