MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BIT,DRILL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumothorax (2012); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is reported as (b)(6) 2019; exact date of postoperative pneumothorax development is unknown.This report is for an unknown drill bit/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 an unknown date, after an unknown surgery, a pneumothorax was observed.A patient underwent an unknown surgery on (b)(6) 2019 and was implanted with locking compression plate (lcp) superior anterior clavicle plate.It is believed that the pneumothorax had occurred while performing temporal fixation of the plate or drilling.During the surgery, the anterior clavicle plate was temporarily fixed with an unknown k-wire and the distal holes on the lcp superior anterior clavicle plate were fixed.Then, the k-wire at the most proximal hole was removed, and drilling was done at the hole using an unknown drill bit.An unknown screw was inserted to the hole, and the surgery was completed.After the operation, it was observed that value of oxygen saturation had increased.X-rays and ct scan were taken and showed that the patient had pneumothorax.Thus, a chest drainage was performed through a trocar.On the following day, the position of the trocar was adjusted, then, the patient was transferred to another hospital.The surgeon commented that the pneumothorax occurred when the proximal hole of the lcp superior anterior clavicle plate was temporally fixed with the unknown k-wire, or when drilling was performed at the hole.There was no stopper mechanism to prevent over-insertion of drill bit in the current devices, and it was too risky.The event was not caused by product problems of the k-wire or the drill.Concomitant devices reported: lcp superior anterior clavicle plate (part #: 04.112.009s, lot #: unknown, quantity: 1), unknown screw (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) unknown drill bit.This is report 2 of 2 for complaint (b)(4).

• 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: 8363848
• MDR Text Key: 136930578
• Report Number: 8030965-2019-61331
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2019
• 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
• Patient Outcome(s): Required Intervention