MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20412

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2017

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 that a screw (part# 50-20412) head broke off while using the trocar.The screw end is still in the patient.Part# 62-00414 x 1 the spring popped out of cheek retractor.However, the case was finished with no surgical delay.

Manufacturer Narrative

The reported event could be confirmed.In the related ti 4690/17 it was stated: one bone screw, cross-pin, 2.0xxxmm broken during surgery, was returned in order to determine the root cause of the failure.The returned screw was examined regarding its dimensions, chemical composition (edx analysis) as well as by light and scanning electron microscopy.The (measurable) dimensions are in accordance with the specification.The chemical composition conforms to the specification - (b)(4).The investigation shows that the screw broke as a result of too high torsional forces in forced rupture mode during the insertion.The fracture surface shows the typical flow structures of a ductile torsional breakage.The root cause of the failure could have been a too small diameter or a too low deepness of the pilot hole.Indications for material or manufacturing related problems were not found in this investigation.No corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported that a screw (part# 50-20412) head broke off while using the trocar.The screw end is still in the patient.Part# 62-00414 x 1 the spring popped out of cheek retractor.However, the case was finished with no surgical delay.

• Brand Name: BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)
• Type of Device: IMPLANT
• 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: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6285839
• MDR Text Key: 66335375
• Report Number: 0008010177-2017-00022
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• 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: 07/18/2017

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: No Information
• Device Catalogue Number: 50-20412
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/30/2017
• Supplement Dates Manufacturer Received: 01/06/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1