MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE INTERM. RIGHT EXTRASHORT; PLATE, FIXATION, BONE

Model Number	54-25683
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the surgeons were performing an open reduction procedure of the right distal radio which the dorsal part was something comminute, a right extractor plate is placed.Distal radio 49mm reference 5425683 lot 1000428950 the oval hole of the branch is fixed to the distal part of the plate with a cortical screw of 2.7x 16mm verifying with x-rays and then fixing the distal part using the 2.0mm locking guide holes which do not block, several drillings are made in different holes but the same happened without blocking the screws, which had been used 2.4mm x 18mm, 20mm, 22mm block t.And then the last branch of the distal hole is fixed proximal part of the plate with a 2.7x14mm cortical screws, it is decided to remove the plate to verify the direction of the holes and their locking function, smart look system, but they do not block the orifices and they are made with a new screws.The surgeon was angry by such event which decides not to use the distal radio system with the used plate any more and to fix the h, distal radio of l apte with kirschner nails 1.25 and 1.1mm.".
Event or Problem Description
As reported: "the surgeons were performing an open reduction procedure of the right distal radio which the dorsal part was something comminute, a right extractor plate is placed.Distal radio 49mm reference 5425683 lot 1000428950 the oval hole of the branch is fixed to the distal part of the plate with a cortical screw of 2.7x 16mm verifying with x-rays and then fixing the distal part using the 2.0mm locking guide holes which do not block, several drillings are made in different holes but the same happened without blocking the screws, which had been used 2.4mm x 18mm, 20mm, 22mm block t.And then the last branch of the distal hole is fixed proximal part of the plate with a 2.7x14mm cortical screws, it is decided to remove the plate to verify the direction of the holes and their locking function, smart look system, but they do not block the orifices and they are made with a new screws.The surgeon was angry by such event which decides not to use the distal radio system with the used plate any more and to fix the h, distal radio of l apte with kirschner nails 1.25 and 1.1mm.".
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information about the event as well as the device must be available in order to determine the exact root cause of the failure.If any further substantial information is provided, the investigation report will be updated.H3 other text : device disposition is unknown.
Additional Manufacturer Narrative
Correction: please refer to d4 lot number, d9/h3 , h4 mfg date, h6 results & conclusion codes.The reported event could not be confirmed, although slight damage in the holes is evident but the reported event could not be reproduced.The device inspection revealed the following: in the received plate, four of the 7 holes were found to be damaged.Metal erosion is quite evident.Overall the plate appears to be free from any other damage.The returned screws were assembled with the returned plate.Even after the damage it was possible to insert the screws and lock with the plate, however it is not recommended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause is deemed to be user related.The deformation in the plate indicates towards an incorrect insertion (possible misalignment and incorrect screw size for the given hole).The event description also supports this proposition as the 2.7mm screw was used in the distal part of the plate where 2.4mm screws are supposed to be used.The damage pattern in the 2.7mm screws indicates towards the same.If any further substantial information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "the surgeons were performing an open reduction procedure of the right distal radio which the dorsal part was something comminute, a right extractor plate is placed.Distal radio 49mm reference 5425683 lot 1000428950 the oval hole of the branch is fixed to the distal part of the plate with a cortical screw of 2.7x 16mm verifying with x-rays and then fixing the distal part using the 2.0mm locking guide holes which do not block, several drillings are made in different holes but the same happened without blocking the screws, which had been used 2.4mm x 18mm, 20mm, 22mm block t.And then the last branch of the distal hole is fixed proximal part of the plate with a 2.7x14mm cortical screws, it is decided to remove the plate to verify the direction of the holes and their locking function, smart look system, but they do not block the orifices and they are made with a new screws.The surgeon was angry by such event which decides not to use the distal radio system with the used plate any more and to fix the h, distal radio of l apte with kirschner nails 1.25 and 1.1mm.".

• Brand Name: VOLAR DR PLATE INTERM. RIGHT EXTRASHORT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12365698
• Report Number: 0008031020-2021-00373
• Device Sequence Number: 4333209
• Product Code: HRS
• UDI-Device Identifier: 07613252614500
• UDI-Public: 07613252614500
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2022

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 Model Number: 54-25683
• Device Catalogue Number: 54-25683
• Device Lot Number: 1000428950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 02/01/2022
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/18/2021; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 61 KG