MAUDE Adverse Event Report: ZIMMER GMBH TI-LOCKING SCREW, SYS2.7, TX8, 14MM; RECON SYSTEM- GRUBBER LAPIDUS-, PLATAR LAPIDUS-, TARSALIS PLATES AND SCREWS

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: medical product: ti-plate right, sys2.7/3.5, item# 28.15.005, lot# 14432.Therapy date: (b)(6) 2018.Medical product: ti-locking screw, sys3.5, hex, 18mm, item# 28.20.018, lot# unknown.Therapy date: (b)(6) 2018.Medical product: ti-locking screw, sys3.5, hex, 16mm, item# 28.20.016, lot# unknown.Therapy date: (b)(6) 2018.Medical product: ti-locking screw, sys2.7, tx8, 12mm, item# 28.25.012, lot# unknown.Therapy date: (b)(6) 2018.Device history records (dhr): the device manufacturing quality records for the plate indicate that the released components met all requirements to perform as intended.The dhr check for the screws could not be performed as the lot number was not available.No trend considering the following event is identified: screws disengage from plate.Event summary: it was reported that the screws were loosened from the threads of the docprice revision plate.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: the docprice plate, two 2.7mm screws and four 3.5mm screws have been returned for an "investiation".The plate as well as the screws still seem to be functional.There are some scratches on the plate, which might have originated during explantation.No other "conspicuoussness" found.Review of product documentation: surgical technique: the surgical technique described the implantation "techique" of the plate and the screws.Product drawing: the product drawing for the plate valid at the time of manufacturing has been reviewed.The threads has been marked to be an inspection characteristic.The dhr indicated that 20 of the 94 parts have been inspected and no failure has been found.Root cause analysis: root cause determination using rmw: implant loosening, non-union due to insufficient stability of plate-screw complex: possible, as it cannot be excluded based on the available information.Malfunction, insufficient device performance or durability due to: user´s disregard of manufacturer´s recommendation, use error (slips, lapses, mistakes, reasonably foreseeable misuse), abnormal use.Beyond risk control: possible, as it cannot be excluded based on the available information.Conclusion summary: it was reported that after one year in vivo, the screws disengaged from the plate.Neither x-rays, operative notes nor office visit notes were received; therefore any contributing factors to this event remain unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.As no x-rays are available, the implant position remains unknown.Moreover, the reported event cannot be confirmed.No additional events have been reported for the part number of the plate.The quality documentation of the plate confirm that it has been manufactured according to specifications.There is no indication for a product failure.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2018-00737, 0009613350-2018-00738, 0009613350-2018-00739, 0009613350-2018-01100.
Event or Problem Description
It was reported that approximately one year post implantation a patient underwent revision surgery due to loosening of the implant.

• Brand Name: TI-LOCKING SCREW, SYS2.7, TX8, 14MM
• Common Device Name: RECON SYSTEM- GRUBBER LAPIDUS-, PLATAR LAPIDUS-, TARSALIS PLATES AND SCREWS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8013777
• Report Number: 0009613350-2018-01101
• Device Sequence Number: 1484182
• Product Code: HRS
• UDI-Device Identifier: 00889024109223
• UDI-Public: 00889024109223
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 2825014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention