MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRILL BIT Ø14 CANN L312 F/AFN; BIT, DRILL

Catalog Number 991.139

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

Udi: (01)gtin unavailable, product made prior to gtin compliance date.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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.A device history record review has been requested.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 (b)(6) reports an event as follows: it was reported that during an osteosynthesis surgery for the femoral trochanteric fracture on (b)(6) 2018, the surgeon had to insert the drill bit a little forcibly because the patient¿s lumbar soft tissue disrupted the drill bit.During the reaming, the drill bit broke in the welded part.All fragments were removed from the patient along with the guide wire.There was a surgical delay of less than 30 minutes.There was no adverse consequence to the patient reported.Concomitant devices: guide wire (part: unknown, lot: unknown, quantity: 1).This report is for a cannulated drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: DRILL BIT Ø14 CANN L312 F/AFN
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8147089
• MDR Text Key: 129812373
• Report Number: 8030965-2018-58879
• Device Sequence Number: 1
• Product Code: HTW
• 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: Physician
• Type of Report: Initial
• Report Date: 11/19/2018

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 Catalogue Number: 991.139
• Device Lot Number: 102050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/10/2018
• 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