MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP SUP ANT CLAVICLE PLATE 8H/RT/120MM; PLATE,FIXATION,BONE

Model Number	02.112.030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a clavicle fracture procedure due to diaphyseal fracture on the right side.During the procedure, the doctor requested a locking compression plate (lcp) superior anterior clavicle plate eight (8) hole but it was missing.The technical assistant provided a seven (7) hole plate instead.As a result, the surgeon was required to change the technique for making a proper fixation to the way the fracture.During the procedure, the use of provisional guidewire was made and there was thorax injury to the patient.For this kind of fracture, the clavicle box contains three (3) sizes of plates, but the logistics department did not send the eight (8) hole plate.There was a forty (40) minute surgical delay.The procedure was successfully completed.The patient status was reported as stable.This report is for one (1) 3.5mm lcp sup ant clavicle plate 8h/rt/120mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
This is report 1 of 2 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional data- event description: 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: 3.5MM LCP SUP ANT CLAVICLE PLATE 8H/RT/120MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8451731
• Report Number: 8030965-2019-62237
• Device Sequence Number: 13860040
• Product Code: HRS
• UDI-Device Identifier: 10886982032874
• UDI-Public: (01)10886982032874
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.112.030
• Device Catalogue Number: 02.112.030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention