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 No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

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 medical procedure, the threaded screw end portion of a bone repositioning device broke off in a patient¿s bone.The broken off piece was removed from the patient.The was no medical intervention.There were no adverse consequences, nor were there any additional symptoms of infections or adverse effects reported.

Manufacturer Narrative

The reported event that the tip of the repositioning instrument broke off could be confirmed according to the provided images via echs.Because the affected instrument was not returned for investigation, a metallurgical examination ¿ indispensable in such cases ¿ cannot be performed making it impossible to determine the exact root cause.However, related to the visual investigation of the provided images the most likely root cause of the breakage could be attributed to an inappropriate user related handling issue.According to that, the repositioning pin was not fully inserted up to the shoulder ring.Related to the determined observations via the provided images 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¿.According to previous conducted investigations further possible root causes include: too high torsional forces during insertion; application of too high bending forces upon to the thread of the pin due to not completely cut off zygoma or other loose bone fragments during repositioning; the instrument was used as a lever; insufficient cleaning caused pitting corrosion ¿ corrosion favours breakages.Related to the submitted production code ag05 the returned device was manufactured after the measurements of capa # 358 were implemented.However, related to the provided images and according to the results within previous conducted investigations the event potentially 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 medical procedure the threaded screw end portion of a bone repositioning device broke off in a patient¿s bone.The broken off piece was removed from the patient.The was no medical intervention.There were no adverse consequences, nor were there any additional symptoms of infections or adverse effects reported.

• 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: 6150604
• MDR Text Key: 62187847
• Report Number: 0008010177-2016-00287
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 62-32440
• Device Lot Number: AG05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: 11/22/2016
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1