MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.016.035S

Device Problems Use of Device Problem (1670); Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Additional pro-code: hsb.Expiration date and lot number 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 as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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, the surgeon underwent open reduction internal fixation surgery for proximal humerus epiphyseal fracture with the multiloc proximal humeral nail and the locking screw.After implanting all devices, the surgeon checked by x-rays and found that the screw in the most distal hole was displaced.The surgeon removed the screw.The surgeon considered that it is dangerous to insert the screw again because it may cause secondary fracture, and he didn't insert screw in the hole.Only one (1) locking screw was inserted in distal locking.The surgery was delayed by less than 30 minutes.No further information is available.Concomitant device reported: titanium multiloc proximal humeral nail (part # 04.016.035s, lot # unknown, quantity 1 and unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This complaint is 2 of 2 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.Concomitant medical products: no concomitant devices are involved in the event.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

Updated event description: it was reported that on july 23, 2019, the patient underwent open reduction internal fixation surgery for proximal humerus epiphyseal fracture with the multiloc proximal humeral nail and the locking screw in question.After implanting all devices, the surgeon checked by x-rays and found that the screw in the most distal hole was displaced.The screw did not pass through the screw hole and came off to the anterior side of the nail.The surgeon removed the screw.Per surgeon the fracture site was in the non-weighted bone and it will be dangerous to insert the screw again because it may cause secondary fracture.That is why surgeon didn¿t insert screw in the hole.Only 1 locking screw was inserted in distal locking.The surgery was delayed by less than 30 minutes.No further information is available.The surgery was delayed by less than 30 minutes.No further information is available.

• Brand Name: 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8907775
• MDR Text Key: 154938845
• Report Number: 8030965-2019-67463
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819431034
• UDI-Public: (01)07611819431034
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.016.035S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR