MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM DRILL BIT/QC/165MM; BIT, DRILL

Catalog Number 310.284

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 11/19/2018

Event Type  Injury  

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.(b)(4).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 (b)(4) reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2018, the surgeon encountered a problem on the 3.5 locking compression plate (lcp) box as well as the drill bits of the locked bolt that were blind.A colibri hand piece was requested.However, the batteries were not charging.The surgeon used a compact air drive with double air hose but it stopped working in the middle of the surgery until it did not work at all.After almost one hour of stoppage of the surgery, the problem was resolved with a use of a nitrogen punch of another company.There was almost an hour surgical delay reported.Patient status and surgical outcome were unknown.Concomitant devices: burr attachment (part 532.101, lot unknown, quantity unknown), double air hose (part 519.510, lot unknown, quantity unknown).This report is for one (1) drill bit.This is report 1 of 3 for (b)(4).

• Brand Name: 2.8MM DRILL BIT/QC/165MM
• Type of Device: BIT, DRILL
• 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 ; 6103142063
• MDR Report Key: 8137460
• MDR Text Key: 129464961
• Report Number: 8030965-2018-58788
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819245891
• UDI-Public: (01)07611819245891
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/06/2018
• 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
• Patient Outcome(s): Required Intervention