MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.019.007

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

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/13/2020

Event Type  Injury  

Manufacturer Narrative

Reporter is a j&j employee.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020 during a humerus intramedullary nail procedure, the connecting screw broke during nail insertion.The nail was implanted but the direction of the locking screw position was not at the correct place.The instrument broke when the nail's end was reach at the entry point.The broken part of the screw was left intact inside the nail at the end.It could not be removed from the patient during surgery because a proper instrument for removal was not available.The removal attachment could not be attached inside the nal as it was blocked by the broken part of the screw at the thread.There was a surgical delay of fifty (50) minutes.The procedure was successfully completed.The patent outcome is unknown.Concomitant device reported: unknown multiloc humeral nail (part# unknown, lot# unknown, quantity 1).This report is for one (1) connecting screw/cannulated for multiloc humeral nail.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Initial reporter state: (b)(6).Device history lot part number: 03.019.007, lot number: 9722107, manufacturing site: hägendorf, release to warehouse date: 27.Nov.2015.Investigation summary: picture review: narrative (connecting screw broken) could be confirmed from provided pictures.Investigation site: cq zuchwil, selected flow: damaged - broken.Visual inspection: the threaded part of the cannulated connecting screw is broken off below the last thread flank.The broken off part was not returned for investigation.In general, the connecting screw presents normal signs of use.Dimensional inspection: further dimensional inspection cannot be done due to the damage incurred.Document/specification review: drawing was reviewed during this investigation.The sub-component 60061264 is not lot tracked.Therefore, the last three potential work orders that were produced prior to lot 9722107 were reviewed.The review has shown that with custom 465 stainless steel the correct material was used and that the hardness was within the specification.Inspection sheet thread of this lot passed all inspection steps during manufacturing without any deviations.Summary: the complaint condition is confirmed as the threaded tip of the connecting screw is broken off.The embedded device condition could not be verified from provided x-rays due to the poor quality of the x-ray.This production lot (9722107) was manufactured in november 2015 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would have contributed to this complaint condition.A definitive root cause for the screw breakage could not be determined based on the provided information.We can only assume that too much force was applied during nail insertion.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10629683
• MDR Text Key: 214640154
• Report Number: 8030965-2020-07717
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819425576
• UDI-Public: (01)07611819425576
• 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: 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.007
• Device Lot Number: 9722107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: MULTILOC HUMERAL
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR