MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXPERT ALFN Ø8.2 CANN R L320 TAN DARK PU; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.031.932S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 2019, during primary surgery there were issues with the imaging.Revision surgery was performed on (b)(6) 2019 as the recon screws had not engaged in the adolescent femoral nail.The nail was left in situ and screws were replaced.No issues with any instruments during the revisions.This complaint involves three (3) devices.This report is for one (1) ø8.2 mm ti adolescent lat entry femoral nail-ex/320 mm/ rt-ster.This is report 2 of 3 for (b)(4).

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.G5: device is not distributed in the united states but is similar to device marketed in the usa.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: EXPERT ALFN Ø8.2 CANN R L320 TAN DARK PU
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9514557
• MDR Text Key: 172893818
• Report Number: 8030965-2019-71406
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819303812
• UDI-Public: (01)07611819303812
• Combination Product (y/n): N
• PMA/PMN Number: K070843
• 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: 12/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.031.932S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/19/2020
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 39