MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.8MM DIA DRILL BIT 16MM STOP LGTH 23MM FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Model Number 03.505.086

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional product code: dzj.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Without a lot number, the device history records review could not be completed as no product was received.Device is not distributed in the united states but is similar to device marketed in the usa.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 on an unknown date that during a ssro surgery on (b)(6) 2019, the 2 drill bits (03.505.086) were broken when drilling left side after the right.The surgery was completed and there was no harm to the patient.It was unknown whether there was a surgical delay or not.Concomitant device reported: unknown hand piece (part # unknown, lot # unknown, quantity 1).This is report 1 of 2 for (b)(4).

• Brand Name: 1.8MM DIA DRILL BIT 16MM STOP LGTH 23MM FOR 90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• 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 19380 ; 6103142063
• MDR Report Key: 9498201
• MDR Text Key: 194800111
• Report Number: 8030965-2019-71284
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013688
• UDI-Public: (01)10887587013688
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082649
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.086
• Device Catalogue Number: 03.505.086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/19/2019
• 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