MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM

Catalog Number 62-32440

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported by a company representative that during a surgical procedure when the surgeon pulled on the device pin the tip portion of the bone repositioning instrument broke off in the patient's zygoma.The broken off residual tip was left in the patient.There were no additional symptoms of infections or adverse effects reported, and the procedure was completed successfully without a delay or medical intervention.

Manufacturer Narrative

The reported event that the tip of the repositioning instrument broke off could be confirmed.The visual inspection revealed that the tip of the repositioning instrument has been broken off at the thread.The broken off thread fragment was left in the patient and was therefore not returned.It was determined that the location of the thread breakage points to the fact that the repositioning pin was not fully inserted until the shoulder ring fits closely to the bone before repositioning the fragments.The microscopic investigation of the breakage surface shows the appearance of a forced rupture caused by too high alternative bending forces during application.At the side of the breakage area plastic deformations are visible which is also an indication of too high bending forces during application.Moreover, the sem investigation confirmed the appearance of a forced rupture caused by too high alternative bending forces.Within the sem investigation the secondary cracks are also visible resulting from an embrittlement of the material caused by the high alternative bending forces during application.According to the determined observations the ifu clearly indicates that ¿the repositioning pin must be carefully inserted up to the shoulder ring before repositioning the loose fragments¿ and ¿the instrument is not to be used as a lever.In case of misuse, the instrument could break¿.Based on investigation, the root cause of the broken off tip of the repositioning instrument was attributed to an inappropriate user related handling issue.According to this, the repositioning pin was not fully inserted up to the shoulder ring and / or the repositioned fragments were not loose (incomplete corticotomy).Thus, too high alternative bending forces have occurred during application which led to the breakage of the repositioning pin.Indications for any material, design or manufacturing related issues could not be found within the investigation.The returned device was manufactured after the measurements of capa # 358 were implemented.However, related to the determined results within the investigation the event did not involve a product problem indicating a non-conformity or unanticipated hazard, therefore no further action is deemed to be required at this time.Product surveillance will continue to monitor complaints of this type for further adverse trends.

Event Description

It was reported by a company representative that during a surgical procedure when the surgeon pulled on the device pin the tip portion of the bone repositioning instrument broke off in the patient's zygoma.The broken off residual tip was left in the patient.There were no additional symptoms of infections or adverse effects reported, and the procedure was completed successfully without a delay or medical intervention.

• Brand Name: UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6114359
• MDR Text Key: 60861111
• Report Number: 0008010177-2016-00278
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 62-32440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: 11/08/2016
• Supplement Dates FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1