MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: TRAUMA

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown drill bit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 the patient was underwent an unknown surgery, but two sets of guide wire was missing in the box.It was interrupted the surgery and 15 minutes delayed.It was unknown if the surgery completed successfully.The patient outcome was unknown.This is report 3 of 3 of (b)(4).

Event Description

The initial complaint was reviewed and it was determined the complaint event involved devices from depuy joint reconstruction not depuy synthese.It was determined there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device.The reported complaint pertains to a service issue and is not a device related complaint.No patient harm provided.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11: b1, b5, h1: the initial complaint was reviewed and it was determined the complaint event involved devices from depuy joint reconstruction not depuy synthes.It was determined there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device.The reported complaint pertains to a service issue and is not a device related complaint.No patient harm provided.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: UNK - DRILL BITS: TRAUMA
• Type of Device: DRILL BIT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9711345
• MDR Text Key: 191322329
• Report Number: 8030965-2020-01132
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention