MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM DRILL BIT W/DEPTH MARK QC/110MM

Model Number 310.534

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Concomitant medical products: drill (part: unknown, lot: unknown, quantity: 1) ¿ (b)(6) 2019.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a foot arthrodesis.During the procedure, a drill bit broke at its distal portion while being used.It was not possible to remove the drill bit completely; a very small fragment, the tip of the drill bit, remained in the bone.Another drill bit from the same box was used to continue the procedure.The procedure was successfully completed with no reported surgical delay.There was no damage to the patient.Concomitant devices: drill (part: unknown, lot: unknown, quantity: 1).This report is for a 2.0mm drill bit w/depth mark.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part: 310.534, lot: f-10271.Manufacturing location: (b)(4), release to warehouse date: aug 04, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.The material was reviewed and the hardness value was confirmed to meet the specification with no non-conformance noted.The instrument(s) was not returned and instead the evaluation will be do based on the supplied image(s) (7 images).The images were reviewed and the complaint condition for broken distal tip was confirmed as three of the images shows the distal tip of drill bit has sheared off.Complaint condition of embedded device could not be confirmed based of the supplied image.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: 2.0MM DRILL BIT W/DEPTH MARK QC/110MM
• Type of Device: BIT
• 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, PA 19380 ; 6103142063
• MDR Report Key: 8591409
• MDR Text Key: 144434929
• Report Number: 8030965-2019-63638
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 10886982186751
• UDI-Public: (01)10886982186751
• 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,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310.534
• Device Catalogue Number: 310.534
• Device Lot Number: F-10271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2010
• 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
• Patient Age: 33 YR