MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 130 DEG LCP DHS PLATE-STANDARD BARREL 6 HOLES/124MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 02.224.206S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: ktt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an under right trochanteric fracture procedure, when checking the material before implantation the screw did not fit on the plate.Another plate and screw were used to complete the surgery.There was no consequence to the patient.Concomitant devices reported: dhs/dcs lag screw 12.7mm thread/100mm-sterile (part number 280.000s, lot 28p2041, quantity 1).This report involves one (1) 130 deg lcp dhs plate-standard barrel 6 holes/124mm-sterile.This is report 2 of 2 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection has shown that the plate is intact and in general in a very good condition, there are no damages at the screw interface visible.Investigation conclusion: the complaint is confirmed as it is impossible to assemble the received plate and screw as complained.The cause of this malfunction can be clearly traced back to a deformation at the screw.There is no indication that the plate did contribute to complained malfunction.The root cause was identified during the performed cq evaluation of the also received dhs/dcs screw and therefore the in the investigation flow listed remaining investigation steps are not required for the plate.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 02.224.206s , lot: 6l14236 , manufacturing site: grenchen, release to warehouse date: 05 november 2019 , expiry date: 01 october 2029.A manufacturing record evaluation was performed for the finished device part: 02.224.206s , lot: 6l14236, and no non-conformances related to malfunction were identified.The nonconformance refered within the dhr is a planned one, that was aimed to monitor and control specific activities to manage all work orders (wo)) which were in wip, during the cutover phase for the transition from old erp (sap p01) to the new erp (sap p02).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 130 DEG LCP DHS PLATE-STANDARD BARREL 6 HOLES/124MM-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10152928
• MDR Text Key: 195093375
• Report Number: 8030965-2020-04148
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819821002
• UDI-Public: (01)07611819821002
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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: 02.224.206S
• Device Lot Number: 6L14236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 06/30/2020
• Patient Sequence Number: 1
• Treatment: DHS/DCS-SCR Ø12.5 L100 SST; DHS/DCS-SCR Ø12.5 L100 SST