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

Catalog Number	PLSL3014
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8356287
• Report Number: 0008031020-2019-00069
• Device Sequence Number: 16480223
• Product Code: HRS
• UDI-Device Identifier: 07613252262138
• UDI-Public: 07613252262138
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 05/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/10/2019; 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other