MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number 441.901

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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, the surgeon attempted to insert the screw into the plate with the machine in the calcar hole left of the plate.The surgeon was unable to insert the screw which was reported as too long.A carbid drill was then used to remove the screw.A surgical delay of fifteen (15) minutes was reported.Concomitant device reported: unk - drill: (part# unknown; lot# unknown; quantity: 1).Unk - drill guide: (part# unknown; lot# unknown; quantity: 1).This report is for one (1) 3.5mm ti lcp proximal humerus plate-standard 3h shaft/90mm.This is report 1 of 2 for (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: part number: 441.901, lot number: 71p7712, manufacturing site: raron, release to warehouse: 29.September 2020.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Visual inspection: the locking thread of hole lg is not present anymore, the hole has been drilled out with a carbide drill bit as described in the complaint description.The locking thread lh next to the drilled out thread is also in a used condition, the anodized layer is worn away at the thread flanks.The other locking threads are in a good condition with no visible damages.There are many scratches on top of the plate, most likely caused during the removal with the carbide drill bit.Functional testing: as the locking thread is not present anymore no functional testing is possible and the complaint condition can therefore not be replicated anymore.Dimensional inspection: the relevant dimensions can due to the damage not be verified anymore.The review of the manufacturing documents has shown that this plate was manufactured, inspected, and released to approved specifications.Document/specification review: the philos and philos long surgical technique was reviewed, related to the screw insertion section can be pointed out: remove drill sleeve and insert the screw with the appropriate screwdriver shaft (hexagonal or stardrive recess) and 1.5 nm torque limiting attachment through the outer sleeve.The sleeve ensures that the locking screw is correctly locked in the plate.The angular stability is reduced if a locking screw is inserted obliquely.Insert the screw manually or with power until a click is heard.If using power, reduce speed when tightening the head of the locking screw into the plate.Investigation conclusion: the complaint is rated as confirmed as the condition of the received devices indicates that it was necessary to drill out the screw head of the locking screw to remove the plate and the screw.Based on the provided information and as the thread in the plate and as well the head of the screw are not present anymore no definitive root cause can be determined, it can only be assumed that any occurrence during the insertion of the locking screw did lead to the jamming of the device.The complaint description states that a machine was used to insert the screw and that the machine was stopped before the screw was fully inserted, no information was provided if a torque limiter was used during this insertion.One possible reason could be that the screw unintentionally inserted too fast and too deep during this preliminary insertion and that the thread was over-tightened afterwards.Another possible reason could be an excessive contact between the thread of the shaft of the locking screw and the plate during the insertion of the screw, which would explain the visible damage at the screw thread.Such a contact could lead to a damage of the locking thread in 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.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: 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10861400
• MDR Text Key: 217094909
• Report Number: 8030965-2020-09015
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819115156
• UDI-Public: (01)07611819115156
• Combination Product (y/n): N
• PMA/PMN Number: K011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.901
• Device Lot Number: 71P7712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/16/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø3.5 SELF-TAP L48 TAN; UNK - GUIDES/SLEEVES/AIMING
• Patient Outcome(s): Required Intervention