MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.0MM / L14MM; PLATE, FIXATION, BONE

Catalog Number PLSL3014

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The following event was reported by clinic: " despite the use of the barrel on the plate anchorage mtp right (ref plp11342), the screw diameter 3 locking does not fit correctly in the hole.Threading problem was observed and 1 wire came out of the screw.The screw protrudes from the plate and a metal wire comes out of the screw.The screw was removed and another screw reinserted.

Event Description

The following event was reported by clinic: " despite the use of the barrel on the plate anchorage mtp right (ref plp11342), the screw diameter3 locking does not fit correctly in the hole.Threading problem was observed and 1 wire came out of the screw.The screw protrudes from the plate and a metal wire comes out of the screw.The screw was removed and another screw reinserted.

Manufacturer Narrative

Correction to concomitant medical products and device evaluated by mfr.The reported event that locking screw anchorage ø3.0mm / l14mm was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the lot number as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.H3 other text : device was not received.

Manufacturer Narrative

Correction to concomitant medical products and device evaluated by mfr.The reported event that locking screw anchorage ø3.0mm / l14mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by an overtorque applied to the part.The visual inspection showed that there are multiple traces of damages all over the screw's head and thread, a sign that large forces were applied while tightening.It is clearly mentioned in the operative technique that " applying excessive torque during screw insertion is not recommended, and may result in damage to the screw head." moreover, there is a metal wire coming out the screw's head contour, such an incident can occur if the screw was inserted with the wrong angle.A tight contact between the plate and the screw's head could have lead to such an event.Therefore, this case is classified as a user related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The following event was reported by clinic: " despite the use of the barrel on the plate anchorage mtp right (ref (b)(4), the screw diameter3 locking does not fit correctly in the hole.Threading problem was observed and 1 wire came out of the screw.The screw protrudes from the plate and a metal wire comes out of the screw.The screw was removed and another screw reinserted.

• Brand Name: LOCKING SCREW ANCHORAGE Ø3.0MM / L14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8356287
• MDR Text Key: 137429302
• Report Number: 0008031020-2019-00069
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252262138
• UDI-Public: 07613252262138
• Combination Product (y/n): N
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLSL3014
• Device Lot Number: L50140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other