MAUDE Adverse Event Report: SYNTHES GMBH SPEEDTITAN COMPRESSION IMPL KIT 25X20X20; STAPLE,FIXATION,BONE

Model Number	SE-2520TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # :(b)(4).Event year is reported as 2020; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Investigation summary: complaint is confirmed as we are able to confirm complaint description, it's visible that the feet of both speedtitan implants are broken off, based on the received pictures.Furthermore, for a further examination it is necessary for us to receive the implant back.Lot number of the involved part was not provided and product was not returned therefore no further investigation possible.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 (information or/and material), 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient had broken implants.Talonavicular surgery done in (b)(6) 2020 and two bme cci speed titan implants was implanted.First implant found to be broken 6 weeks after surgery, second implant found to be broken 5 months after surgery.Despite broken implants, surgeon was suggested that the patient is painless and no need revision or removal surgery.The patient is not experiencing adverse situation and no additional medical intervention required.There were no patient consequences are reported.This complaint involves two (2) devices.This report is for (1) speedtitan(tm) implant kit 25 x 20 mm.This report is 1 of 2 (b)(4).

• Brand Name: SPEEDTITAN COMPRESSION IMPL KIT 25X20X20
• Common Device Name: STAPLE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11686678
• Report Number: 8030965-2021-03033
• Device Sequence Number: 3097445
• Product Code: JDR
• UDI-Device Identifier: 00810633021576
• UDI-Public: 00810633021576
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: SE-2520TI
• Device Catalogue Number: SE-2520TI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1